PRONEB ULTRA MODEL NUMBER 85B0100
Device Facts
| Record ID | K002862 |
|---|---|
| Device Name | PRONEB ULTRA MODEL NUMBER 85B0100 |
| Applicant | Pari Holding Co. |
| Product Code | BTI · Anesthesiology |
| Decision Date | Mar 13, 2001 |
| 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.
