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510(k) K980906

TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO by Transonic Systems, Inc. — Product Code MQS

K980906 is an FDA 510(k) premarket notification submitted by Transonic Systems, Inc. for the device "TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO". The FDA issued a decision of Substantially Equivalent on October 6, 1998. 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
October 6, 1998
Date Received
March 10, 1998
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)
  • K021571 — TRANSONIC FLOW-QC SET MODEL ADT1010 (August 12, 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)
  • K021571 — TRANSONIC FLOW-QC SET MODEL ADT1010 (August 12, 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)

FDA data resources