Sorin Connect Data Management System
FDA 510(k) K131816 · Sorin Group Deutschland GmbH
510(k) numberK131816
Submission
- Device name
- Sorin Connect Data Management System
- Applicant
- Sorin Group Deutschland GmbH
Munich, DE - Received
- June 20, 2013
- Decision date
- July 23, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
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| K172969 | Essence 55S Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 01/26/2018SE |
| K170460 | Sorin ConnectDXJ · Special | Sorin Group Deutschland GmbH | 06/08/2017SE |
| K170537 | Nexxis OR, NexxisDXJ · Special | Barco N.V. | 04/21/2017SE |
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| K170460 | Sorin ConnectDXJ · Special | 06/08/2017SE |
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| K140012 | Sorin FlexthermDWC · Special | 01/31/2014SE |
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| K103762 | Sorin C5 System; 85/C5 Mast Roller Pump System 150(1X RP 150 and Control Panel with…DTQ · Special | 01/20/2011SE |
| K103468 | Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems)DWA · Traditional | 01/20/2011SE |
| K103469 | Stockert Air Purge Control System Model 23-45-05KRL · Traditional | 01/18/2011SE |
| K103168 | B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head)DRY · Traditional | 01/06/2011SE |
| K101046 | Stockert S5 System and Gas Blender and Sorin C5 SystemDTX · Traditional | 12/09/2010SE |
| K093882 | Sorin C5 System Model 58-00-00DTQ · Special | 01/15/2010SE |
Questions and answers
When was Sorin Connect Data Management System cleared by the FDA?
Sorin Connect Data Management System (K131816) received a 510(k) decision of Substantially Equivalent on July 23, 2013, 33 days after the submission was received.
What is the product code of K131816?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.