The following data is part of a premarket notification filed by Intl. Medical Devices Ltd. with the FDA for Respiration Monitor 1000.
| Device ID | K820778 |
| 510k Number | K820778 |
| Device Name: | RESPIRATION MONITOR 1000 |
| Classification | Monitor, Breathing Frequency |
| Applicant | INTL. MEDICAL DEVICES LTD. 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 | 1982-03-23 |
| Decision Date | 1982-05-03 |