The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Edentec Model 2000w System 700 Monitor.
| Device ID | K901060 |
| 510k Number | K901060 |
| Device Name: | EDENTEC MODEL 2000W SYSTEM 700 MONITOR |
| Classification | Oximeter |
| Applicant | EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Contact | Gary Syring |
| Correspondent | Gary Syring 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 | 1990-03-06 |
| Decision Date | 1990-05-15 |