The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Infant Monitor.
| Device ID | K820645 |
| 510k Number | K820645 |
| Device Name: | INFANT MONITOR |
| Classification | Monitor, Breathing Frequency |
| Applicant | HEALTHDYNE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-09 |
| Decision Date | 1982-04-15 |