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510(k) K192785

OptiScanner® 5000 Glucose Monitoring System by Optiscan Biomedical Corporation — Product Code LZF

K192785 is an FDA 510(k) premarket notification submitted by Optiscan Biomedical Corporation for the device "OptiScanner® 5000 Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on February 5, 2020. 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
February 5, 2020
Date Received
September 30, 2019
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

  • 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)
  • 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