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510(k) K162042

OptiScanner 5000 Glucose Monitoring System by Optiscan Biomedical Corp. — Product Code LZF

K162042 is an FDA 510(k) premarket notification submitted by Optiscan Biomedical Corp. for the device "OptiScanner 5000 Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on October 16, 2017. The device falls under product code LZF (Pump, Infusion, Analytical Sampling), a Class II device regulated under 21 CFR 880.5725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2017
Date Received
July 25, 2016
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 for product code LZF

  • K192785 — OptiScanner® 5000 Glucose Monitoring System (February 5, 2020)
  • K011238 — RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM (January 8, 2002)
  • 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)
  • K882830 — INFUSION PUMP (December 30, 1988)

FDA data resources