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510(k) K882830

INFUSION PUMP by Pemlab Corp. — Product Code LZF

K882830 is an FDA 510(k) premarket notification submitted by Pemlab Corp. for the device "INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on December 30, 1988. 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
December 30, 1988
Date Received
July 8, 1988
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)
  • 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)

FDA data resources