The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Ecg/respiration Stimulator.
| Device ID | K802205 |
| 510k Number | K802205 |
| Device Name: | ECG/RESPIRATION STIMULATOR |
| Classification | Monitor, Breathing Frequency |
| Applicant | HEALTHDYNE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-11 |
| Decision Date | 1980-10-03 |