21 C.F.R. § 868.6250

Portable air compressor.

Last amended: 2019Year: 2026Length: 71 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 868.6250 (2026)

(a) Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices. (b) Classification. Class II (special 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 84 FR 71811, Dec. 30, 2019]
Cross-references to the CFR
868.9.
21 C.F.R. § 868.6250: Portable air compressor. | Justis AI