The following data is part of a premarket notification filed by Flexco Medical Instruments with the FDA for The Hayek Oscillator.
| Device ID | K903745 |
| 510k Number | K903745 |
| Device Name: | THE HAYEK OSCILLATOR |
| Classification | Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| Applicant | FLEXCO MEDICAL INSTRUMENTS KIRCHWEG 151, 8102 OBERENGSTRINGEN Zurich, Switzerland, CH |
| Contact | Edith Muller |
| Correspondent | Edith Muller FLEXCO MEDICAL INSTRUMENTS KIRCHWEG 151, 8102 OBERENGSTRINGEN Zurich, Switzerland, CH |
| Product Code | BYT |
| CFR Regulation Number | 868.5935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-16 |
| Decision Date | 1990-11-09 |