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510(k) K022963

TRANSONIC SYRINGE WARMER, MODEL SYR-1000 by Transonic Systems, Inc. — Product Code MQS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2002
Date Received
September 6, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Hemodialysis, Access Recirculation Monitoring
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Transonic Systems, Inc.

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  • K113821 — TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM (September 7, 2012)
  • 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)
  • 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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  • K992227 — CRIT-LINE MONITOR III (CLM III) (July 30, 1999)
  • K984194 — HP M2376A DEVICE LINK SYSTEM (April 30, 1999)
  • K982412 — MODIFICATION OF CRIT-LINE MONITOR III (CLM III) (October 9, 1998)