The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Edentec Model 2800/2801 Oximeter/pulse Oximeter.
| Device ID | K881820 |
| 510k Number | K881820 |
| Device Name: | EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Contact | Ed Schuck |
| Correspondent | Ed 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 | 1988-04-29 |
| Decision Date | 1988-07-18 |