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510(k) K113821

TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM by Transonic Systems, Inc. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2012
Date Received
December 27, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

Other clearances by Transonic Systems, Inc.

  • K140740 — TRANSONIC TISSUE PERFUSION MONITOR (July 23, 2015)
  • K134051 — TRANSONIC ELSA SYSTEM (January 29, 2015)
  • K134035 — TRANSONIC HCM 103 SYSTEM (September 17, 2014)
  • K140017 — TRANSONIC HCM 102 SYSTEM (September 16, 2014)
  • K112657 — AUREFLO MONITORING SYSTEM (December 21, 2011)
  • K080116 — TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM (September 8, 2008)
  • K033424 — ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MO (December 11, 2003)
  • K022963 — TRANSONIC SYRINGE WARMER, MODEL SYR-1000 (December 4, 2002)
  • K021571 — TRANSONIC FLOW-QC SET MODEL ADT1010 (August 12, 2002)
  • K010253 — ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ (March 19, 2002)

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