21 CFR 868.6250 — Compressor, Air, Portable
Anesthesiology (AN) · Part 868 Subpart G—Miscellaneous · § 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 Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BTI | Compressor, Air, Portable | 2 | 74 |
Special Controls
BTI — Compressor, Air, Portable
*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.
eCFR
