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510(k) K113214

TLINK DATA MANAGEMENT SYSTEM (DMS) by Terumo Cardiovascular Systems Corp. — Product Code DXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2012
Date Received
October 31, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Cathode-Ray Tube, Medical
Device Class
Class II
Regulation Number
870.2450
Review Panel
CV
Submission Type

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  • K130359 — CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX (March 13, 2013)
  • K123039 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (November 20, 2012)
  • K112587 — ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASS (December 19, 2011)
  • K112229 — SARN CENTRIFUGAL PUMP (December 9, 2011)

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