The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Edentec Model 4700 Scanner.
| Device ID | K884388 |
| 510k Number | K884388 |
| Device Name: | EDENTEC MODEL 4700 SCANNER |
| Classification | Recorder, Paper Chart |
| 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 | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-18 |
| Decision Date | 1989-01-10 |