The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Edentec Model 2001 Modular Memory Unit (mmu).
| Device ID | K892227 |
| 510k Number | K892227 |
| Device Name: | EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) |
| Classification | Recorder, Magnetic Tape, Medical |
| 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 | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-04 |
| Decision Date | 1989-06-20 |