The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Edentec Model 3711 Digital Recorder.
| Device ID | K910870 |
| 510k Number | K910870 |
| Device Name: | EDENTEC MODEL 3711 DIGITAL RECORDER |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| 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 | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-01 |
| Decision Date | 1991-08-29 |