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510(k) K021571

TRANSONIC FLOW-QC SET MODEL ADT1010 by Transonic Systems, Inc. — Product Code MQS

K021571 is an FDA 510(k) premarket notification submitted by Transonic Systems, Inc. for the device "TRANSONIC FLOW-QC SET MODEL ADT1010". The FDA issued a decision of Substantially Equivalent on August 12, 2002. The device falls under product code MQS (System, Hemodialysis, Access Recirculation Monitoring), a Class II device regulated under 21 CFR 876.5820. Transonic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2002
Date Received
May 14, 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.

  • 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)
  • 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)
  • K022963 — TRANSONIC SYRINGE WARMER, MODEL SYR-1000 (December 4, 2002)
  • K010253 — ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ (March 19, 2002)

Other clearances for product code MQS

  • K232283 — PhySoftAMS® (December 14, 2023)
  • K180410 — Dosis SAM (January 16, 2019)
  • K130579 — PHYSOFT AMS (December 19, 2013)
  • K042566 — VASC-ALERT (November 8, 2004)
  • K022963 — TRANSONIC SYRINGE WARMER, MODEL SYR-1000 (December 4, 2002)
  • K001763 — CRIT-LINE MONITOR III (CLM III) (December 20, 2000)
  • K993587 — HP M2376A DEVICE LINK SYSTEM (January 20, 2000)
  • 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)

FDA data resources