The following data is part of a premarket notification filed by Surgiceye Gmbh with the FDA for Declipsespect Viewer.
| Device ID | K123917 |
| 510k Number | K123917 |
| Device Name: | DECLIPSESPECT VIEWER |
| Classification | Probe, Uptake, Nuclear |
| Applicant | SURGICEYE GMBH Friedenstr. 18a Munich, DE 81671 |
| Contact | Moritz Hoyer |
| Correspondent | Moritz Hoyer SURGICEYE GMBH Friedenstr. 18a Munich, DE 81671 |
| Product Code | IZD |
| CFR Regulation Number | 892.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-19 |
| Decision Date | 2013-01-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| ESURSE13010002 | K123917 | 000 |