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510(k) K922997

VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD. by Via Medical Corp. — Product Code LZF

K922997 is an FDA 510(k) premarket notification submitted by Via Medical Corp. for the device "VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD.". The FDA issued a decision of Substantially Equivalent (kit, denovo) on January 11, 1994. The device falls under product code LZF (Pump, Infusion, Analytical Sampling), a Class II device regulated under 21 CFR 880.5725. Via Medical Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
January 11, 1994
Date Received
June 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Analytical Sampling
Device Class
Class II
Regulation Number
880.5725
Review Panel
CH
Submission Type

Other clearances by Via Medical Corp.

  • K935778 — VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM (December 5, 1996)
  • K951739 — PUMP/BLOOD CHEMISTRY MONITOR (February 28, 1996)
  • K920438 — VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM (October 22, 1993)

Other clearances for product code LZF

  • K192785 — OptiScanner® 5000 Glucose Monitoring System (February 5, 2020)
  • K162042 — OptiScanner 5000 Glucose Monitoring System (October 16, 2017)
  • K011238 — RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM (January 8, 2002)
  • K951739 — PUMP/BLOOD CHEMISTRY MONITOR (February 28, 1996)
  • K920438 — VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM (October 22, 1993)
  • K882830 — INFUSION PUMP (December 30, 1988)

FDA data resources