The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Edentrace 670 System Multichannel Recorder W/oxim..
| Device ID | K893561 |
| 510k Number | K893561 |
| Device Name: | EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. |
| Classification | Recorder, Paper Chart |
| 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 | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-09 |
| Decision Date | 1989-08-25 |