K921726 is an FDA 510(k) clearance for the HAYEK OSCILLATOR, MODIFICATION. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on April 23, 1992, 15 days after receiving the submission on April 8, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K921726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 1992 |
| Decision Date | April 23, 1992 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBK — Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |