The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Edentec Multi-channel Recorder.
| Device ID | K873081 |
| 510k Number | K873081 |
| Device Name: | EDENTEC MULTI-CHANNEL RECORDER |
| Classification | Oximeter |
| Applicant | EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Contact | Edward Schuck |
| Correspondent | Edward Schuck EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-05 |
| Decision Date | 1987-11-17 |