The following data is part of a premarket notification filed by Healthdyne Technologies, Inc. with the FDA for Model 1700 Tranquility Bilevel System.
| Device ID | K970173 |
| 510k Number | K970173 |
| Device Name: | MODEL 1700 TRANQUILITY BILEVEL SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | HEALTHDYNE TECHNOLOGIES, INC. 1850 PARKWAY PLACE Marietta, GA 30067 |
| Contact | Timothy Y Cowart |
| Correspondent | Timothy Y Cowart HEALTHDYNE TECHNOLOGIES, INC. 1850 PARKWAY PLACE Marietta, GA 30067 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-16 |
| Decision Date | 1997-04-16 |