510(k) K131816
K131816 is an FDA 510(k) premarket notification submitted by Sorin Group Deutschland GmbH for the device "SORIN CONNECT DATA MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on July 23, 2013. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Sorin Group Deutschland GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2013
- Date Received
- June 20, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Display, Cathode-Ray Tube, Medical
- Device Class
- Class II
- Regulation Number
- 870.2450
- Review Panel
- CV
- Submission Type