The following data is part of a premarket notification filed by Sicat Gmbh & Co. Kg with the FDA for Sicat Function.
| Device ID | K133320 |
| 510k Number | K133320 |
| Device Name: | SICAT FUNCTION |
| Classification | System, Image Processing, Radiological |
| Applicant | SICAT GMBH & CO. KG BRUNNENALLEE 6 Bonn, DE D-53177 |
| Contact | Manfred Breuer |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-10-28 |
| Decision Date | 2014-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D776SUITEV20 | K133320 | 000 |
| D776FUNCTIONV20 | K133320 | 000 |
| D776SUITEV200 | K133320 | 000 |
| D776FUNCTIONV200 | K133320 | 000 |
| D77664556330 | K133320 | 000 |
| D776FUNCTIONV20400 | K133320 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SICAT FUNCTION 79142787 4665280 Live/Registered |
SiCAT GmbH & Co. KG 2013-08-07 |