The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Healthdyne's Apnea/heart Monitor, Model 900s.
| Device ID | K892006 |
| 510k Number | K892006 |
| Device Name: | HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274 |
| Contact | Tim Cowart |
| Correspondent | Tim Cowart HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-28 |
| Decision Date | 1989-05-23 |