AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL
Device Facts
| Record ID | K820079 |
|---|---|
| Device Name | AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL |
| Applicant | James L. Geraci & Associates, Inc. |
| Product Code | BTI · Anesthesiology |
| Decision Date | Feb 5, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.6250 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
