The following data is part of a premarket notification filed by New Dimensions In Medicine, Inc. with the FDA for Respiration Monitor Type Mr-10.
| Device ID | K822077 |
| 510k Number | K822077 |
| Device Name: | RESPIRATION MONITOR TYPE MR-10 |
| Classification | Monitor, Apnea, Facility Use |
| Applicant | NEW DIMENSIONS IN MEDICINE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FLS |
| CFR Regulation Number | 868.2377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-15 |
| Decision Date | 1982-10-06 |