Source: https://www.law.cornell.edu/cfr/text/21/882.1500
Timestamp: 2015-03-06 06:20:01
Document Index: 388035

Matched Legal Cases: ['art 882', '§ 882', 'art 807', '§ 882', 'art 820', '§ 820', '§ 820']

21 CFR 882.1500 - Esthesiometer. | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 882 › Subpart B › Section 882.1500 21 CFR 882.1500 - Esthesiometer.
There are 2 Updates appearing in the Federal Register for 21 CFR 882. View below or at eCFR (GPOAccess)
§ 882.1500
Esthesiometer.
An esthesiometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician or other examiner and which is used to determine whether a patient has tactile sensitivity.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.
[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000]
Title 21 published on 2014-04-01The following are only the Rules published in the Federal Register after the published date of Title 21.For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.2014-07-08; vol. 79 # 130 - Tuesday, July 8, 201479 FR 38457 - Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulator for Headache
Title 21 published on 2014-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 882 after this date.2014-07-08; vol. 79 # 130 - Tuesday, July 8, 201479 FR 38457 - Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulator for Headache