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 |