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510(k) K103168

B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) by Sorin Group Deutschland GmbH — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2011
Date Received
October 27, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4330
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)
  • 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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