The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Infant Monitor 16900.
| Device ID | K843546 |
| 510k Number | K843546 |
| Device Name: | INFANT MONITOR 16900 |
| Classification | Monitor, Breathing Frequency |
| Applicant | HEALTHDYNE, INC. 2253 NORTHWEST PKWY. Marietta, GA 30067 |
| Contact | Tim Cowart |
| Correspondent | Tim Cowart HEALTHDYNE, INC. 2253 NORTHWEST PKWY. Marietta, GA 30067 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-10 |
| Decision Date | 1984-10-10 |