K924341 is an FDA 510(k) clearance for the HAYEK OSCILLATOR(TM). This device is classified as a Ventilator, External Body, Negative Pressure, Adult (cuirass) (Class II - Special Controls, product code BYT).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on July 21, 1993, 328 days after receiving the submission on August 27, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5935.
| 510(k) Number | K924341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1992 |
| Decision Date | July 21, 1993 |
| Days to Decision | 328 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BYT — Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5935 |