The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Syneflash & Syneview.
| Device ID | K990727 |
| 510k Number | K990727 |
| Device Name: | SYNEFLASH & SYNEVIEW |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ELA MEDICAL, INC. 2950 XENIUM LN. NORTH Plymouth, MN 55441 |
| Contact | Catherine G Goble |
| Correspondent | Catherine G Goble ELA MEDICAL, INC. 2950 XENIUM LN. NORTH Plymouth, MN 55441 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-05 |
| Decision Date | 1999-11-26 |
| Summary: | summary |