§ 868.5320. Reservoir bag.
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/us/cfr/t21/s§ 868.5320·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001]
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§ 868.5320
Reservoir bag.
Fed. Reg.×1
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