The following data is part of a premarket notification filed by Sicat Gmbh & Co. Kg with the FDA for Sicat Endo.
| Device ID | K180262 |
| 510k Number | K180262 |
| Device Name: | SICAT Endo |
| Classification | System, Image Processing, Radiological |
| Applicant | SICAT GmbH & Co. KG Brunnenallee 6 Bonn, DE 53177 |
| Contact | Manfred Breuer |
| Correspondent | Frederik Kunze SICAT GmbH & Co. KG Brunnenallee 6 Bonn, DE 53177 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-30 |
| Decision Date | 2018-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D776ENDOV20 | K180262 | 000 |
| D776ENDOV200 | K180262 | 000 |
| D77666224630 | K180262 | 000 |
| D776ENDOV20400 | K180262 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SICAT ENDO 79143705 4673498 Live/Registered |
SiCAT GmbH & Co. KG 2013-08-09 |
![]() SICAT ENDO 79142440 4669203 Live/Registered |
SiCAT GmbH & Co. KG 2013-08-09 |