The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Healthdyne's Event Recorder System.
| Device ID | K860254 |
| 510k Number | K860254 |
| Device Name: | HEALTHDYNE'S EVENT RECORDER SYSTEM |
| Classification | Monitor, Breathing Frequency |
| 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 | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-24 |
| Decision Date | 1986-01-30 |