Source: http://www.readanybookx.com/cfr-2012-title21-vol8-sec868-5690-pdf-i223708
Timestamp: 2019-04-19 17:09:37+00:00

Document:
A rebreathing de- this generic type of device. vice is a device that enables a patient (b) Classification. Class II (perform- to rebreathe exhaled gases. It may be ance standards). nebulizer (atomizer). (b) Classification. Class I (general con- (a) Identification.
Class II (perform- subpart E of part 807 of this chapter ance standards). subject to the limitations in § 868.9. § 868.2600 Airway pressure monitor. [47 FR 31142, July 16, 1982, as amended at 61 (a) Identification. An airway pressure FR 1119, Jan.
thesia is a device used to administer to (a) Identification. A blow bottle is a a patient, continuously or intermit- device that is intended for medical pur- tently, a general inhalation anesthetic poses to induce a forced expiration and to maintain a patient’s ventila- from a patient.
subpart E of part 807 of this chapter (a) Identification. A powered percussor subject to § 868.9. is a device that is intended to transmit [47 FR 31142, July 16, 1982, as amended at 65 vibration through a patient’s chest FR 2313, Jan. drainage and that may be powered by (a) Identification.
Class II (perform- subpart E of part 807 of this chapter ance standards). subject to § 868.9. § 868.1870 Gas volume calibrator. [47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000] (a) Identification.
subject to the limitations in § 868.9. (a) Identification. A breathing circuit [47 FR 31142, July 16, 1982, as amended at 61 circulator is a turbine device that is FR 1120, Jan.
637 VerDate Mar<15>2010 18:34 May 10, 2012 Jkt 226074 PO 00000 Frm 00647 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT ofr150 PsN: PC150 § 1020.30 21 CFR Ch. I (4–1–12 Edition) (3) Quick-change x-ray tubes. The re- ator.
ments in this part. You must submit (3) You must maintain the device the request to us in writing. Your re- complaint files established under this quest must include information nec- section at your principal business es- essary to identify you and the device; a tablishment.
being placed in commercial distribu- [68 FR 14137, Mar. 24, 2003] tion. [52 FR 33702, Sept. 4, 1987, as amended at 61 § 888.3570 Knee joint femoral (hemi- FR 50710, Sept. 27, 1996] knee) metallic uncemented pros- thesis.

References: § 868
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 § 1020
 § 888