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510(k) K935778

VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM by Via Medical Corp. — Product Code CCE

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
December 5, 1996
Date Received
December 3, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
Device Class
Class II
Regulation Number
868.1200
Review Panel
AN
Submission Type

Other clearances by Via Medical Corp.

  • K951739 — PUMP/BLOOD CHEMISTRY MONITOR (February 28, 1996)
  • K922997 — VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD. (January 11, 1994)
  • K920438 — VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM (October 22, 1993)

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  • K896311 — OPTEX BLOOD GAS MONITORING SYSTEM (January 3, 1990)
  • K890624 — TISSUE OXYGEN MONITOR SYSTEM, MODEL II (December 22, 1989)
  • K895149 — NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY (November 28, 1989)
  • K895150 — CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING (November 28, 1989)
  • K884063 — BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM (December 16, 1988)
  • K875225 — UMBILICAL ARTERY OXYGEN SENSOR (March 4, 1988)
  • K872896 — UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 (February 12, 1988)