The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Model 900s Apnea/heart Monitor.
| Device ID | K903287 |
| 510k Number | K903287 |
| Device Name: | MODEL 900S APNEA/HEART MONITOR |
| Classification | Monitor, Breathing Frequency |
| 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 | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-11 |
| Decision Date | 1990-08-17 |