The following data is part of a premarket notification filed by Med Dyne Inst., Inc. with the FDA for Medi-dyne Apnea Monitor.
| Device ID | K760635 |
| 510k Number | K760635 |
| Device Name: | MEDI-DYNE APNEA MONITOR |
| Classification | Monitor, Apnea, Facility Use |
| Applicant | MED DYNE INST., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FLS |
| CFR Regulation Number | 868.2377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-09-13 |
| Decision Date | 1976-09-21 |