The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Pressure Support Ventilatory Assist System (psvas).
| Device ID | K950331 |
| 510k Number | K950331 |
| Device Name: | PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274 |
| Contact | Timothy Y Cowart |
| Correspondent | Timothy Y Cowart HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-27 |
| Decision Date | 1995-09-21 |