The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Sorin Connect Data Management System.
| Device ID | K131816 |
| 510k Number | K131816 |
| Device Name: | SORIN CONNECT DATA MANAGEMENT SYSTEM |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | SORIN GROUP DEUTSCHLAND GMBH LINDBERGH STRASSE 25 Munchen, DE 80939 |
| Contact | Renate Goebert |
| Correspondent | Olaf Teichert TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-06-20 |
| Decision Date | 2013-07-23 |
| Summary: | summary |