Source: https://www.law.cornell.edu/cfr/text/21/part-880/subpart-C
Timestamp: 2017-12-13 22:46:20
Document Index: 311210606

Matched Legal Cases: ['art 880', 'art 880', 'art 880', '§ 880', '§ 880', '§ 880', '§ 880', '§ 880', '§ 880', '§ 880', '§ 880', '§ 880', '§ 880', '§ 880', '§ 880', '§ 880', 'art 880', 'arts 878']

21 CFR Part 880, Subpart C - General Hospital and Personal Use Monitoring Devices | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 880 › Subpart C
21 CFR Part 880, Subpart C - General Hospital and Personal Use Monitoring Devices
§ 880.2200 Liquid crystal forehead temperature strip.
§ 880.2400 Bed-patient monitor.
§ 880.2420 Electronic monitor for gravity flow infusion systems.
§ 880.2460 Electrically powered spinal fluid pressure monitor.
§ 880.2500 Spinal fluid manometer.
§ 880.2700 Stand-on patient scale.
§ 880.2720 Patient scale.
§ 880.2740 Surgical sponge scale.
§ 880.2800 Sterilization process indicator.
§ 880.2900 Clinical color change thermometer.
§ 880.2910 Clinical electronic thermometer.
§ 880.2920 Clinical mercury thermometer.
§ 880.2930 Apgar timer.
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 880 after this date.
81 FR 91722 - Banned Devices; Powdered Surgeon&apos;s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon&apos;s Glove
FR Doc. 2016-30382
RIN 0910-AH02
21 CFR Parts 878, 880, and 895
The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon&apos;s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon&apos;s Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices.
81 FR 91731 - General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet
FR Doc. 2016-30193
81 FR 15173 - Banned Devices; Proposal To Ban Powdered Surgeon&apos;s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon&apos;s Glove
FR Doc. 2016-06360
The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon&apos;s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon&apos;s Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is proposing these devices be banned.
80 FR 72587 - Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device
FR Doc. 2015-29660
Docket No. FDA-2015-N-3838
This order is effective November 20, 2015. The classification was applicable on December 20, 2011.
The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the UV radiation chamber disinfection device classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
80 FR 60809 - General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet
FR Doc. 2015-25627
Submit either electronic or written comments by December 7, 2015. See section VII of this document for the proposed effective date of a final rule based on this proposed rule.
The Food and Drug Administration (FDA) is proposing to rename pediatric hospital beds as pediatric medical cribs and establish special controls for these devices. FDA is also proposing to establish a separate classification regulation for medical bassinets, previously under the pediatric hospital bed classification regulation, as a class II (special controls) device. The proposed regulation for both pediatric medical cribs and medical bassinets would also include the Consumer Product Safety Commission&apos;s (CPSC) mattress flammability standards for the mattresses intended for use with these devices. In addition, this proposed rule would require prescription use of pediatric medical cribs and bassinets.
FR Doc. 2014-11174
The Food and Drug Administration (FDA) is classifying the intravascular administration set, automated air removal system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the intravascular administration set, automated air removal system&apos;s classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
78 FR 28733 - Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the Ingestible Event Marker
FR Doc. 2013-11628