§868.6250. Portable air compressor.
21 C.F.R. § 868.6250
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.
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.
Notes, amendments, and revision history
Amendments
[47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 47 FR 31142, July 16, 1982, unless otherwise noted.
Amendments
[47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019]