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510(k) K131816

SORIN CONNECT DATA MANAGEMENT SYSTEM by Sorin Group Deutschland GmbH — Product Code DXJ

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

Other clearances by Sorin Group Deutschland GmbH

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  • K112225 — SORIN CENTRIFUGAL PUMP 5 (CP5) (September 20, 2011)
  • K103468 — STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) (January 20, 2011)
  • K103762 — SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL W (January 20, 2011)
  • K103469 — STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 (January 18, 2011)
  • K103168 — B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) (January 6, 2011)
  • K101046 — STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM (December 9, 2010)
  • K093882 — SORIN C5 SYSTEM MODEL 58-00-00 (January 15, 2010)

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