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FDA 510(k)

INFUSION PUMP

K-Number: K882830 · 1988-12-30

ApplicantPemlab Corp.
Decision Date1988-12-30
Product CodeLZF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Pemlab Corp.. It received FDA 510(k) clearance on 1988-12-30 under 510(k) number K882830. The device is classified under product code LZF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFUSION PUMP?

INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1988-12-30. The listed applicant is Pemlab Corp.. The 510(k) number is K882830.

When did INFUSION PUMP receive FDA 510(k) clearance?

INFUSION PUMP received FDA 510(k) clearance on 1988-12-30, under 510(k) number K882830.

Who is the listed applicant for INFUSION PUMP?

The FDA 510(k) record lists Pemlab Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFUSION PUMP?

The FDA product code for INFUSION PUMP is LZF.

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Related Devices (Code: LZF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192785OptiScanner® 5000 Glucose Monitoring SystemOptiscan Biomedical CorporationK162042OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical Corp.K011238RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEMMetracor Technologies, Inc.K951739PUMP/BLOOD CHEMISTRY MONITORVia Medical Corp.K922997VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD.Via Medical Corp.K920438VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEMVia Medical Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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