K895485 is an FDA 510(k) clearance for the BIRD (IPV) NONCONTINUOUS VENTILATORS. This device is classified as a Device, Positive Pressure Breathing, Intermittent (Class II - Special Controls, product code NHJ).
Submitted by Percussionaire Corp. (Sandpoint, US). The FDA issued a Cleared decision on October 30, 1989, 49 days after receiving the submission on September 11, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K895485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1989 |
| Decision Date | October 30, 1989 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | NHJ — Device, Positive Pressure Breathing, Intermittent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |