The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Healthdyne Apnea/heart Monitor, Model 900.
| Device ID | K874695 |
| 510k Number | K874695 |
| Device Name: | HEALTHDYNE APNEA/HEART MONITOR, MODEL 900 |
| 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 | 1987-11-16 |
| Decision Date | 1988-01-29 |