The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Hayek Oscillator(tm).
| Device ID | K924341 |
| 510k Number | K924341 |
| Device Name: | HAYEK OSCILLATOR(TM) |
| Classification | Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Richard G Confer |
| Correspondent | Richard G Confer RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | BYT |
| CFR Regulation Number | 868.5935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-27 |
| Decision Date | 1993-07-21 |