21 C.F.R. · Food and Drugs
21 C.F.R. § 868.5700

Nonpowered oxygen tent.

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21 C.F.R. § 868.5700 — Nonpowered oxygen tent.

§ 868.5700 Nonpowered oxygen tent. (a) Identification. A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods. (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 § 868.9. [47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]

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21 C.F.R. § 868.5700
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