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FDA 510(k)

SIMPLICITY INFUSION PUMP MODEL 2100A

K-Number: K803078 · 1981-01-28

ApplicantCritikon Company, LLC
Decision Date1981-01-28
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SIMPLICITY INFUSION PUMP MODEL 2100A is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1981-01-28 under 510(k) number K803078. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLICITY INFUSION PUMP MODEL 2100A?

SIMPLICITY INFUSION PUMP MODEL 2100A is a medical device that received FDA 510(k) clearance on 1981-01-28. The listed applicant is Critikon Company, LLC. The 510(k) number is K803078.

When did SIMPLICITY INFUSION PUMP MODEL 2100A receive FDA 510(k) clearance?

SIMPLICITY INFUSION PUMP MODEL 2100A received FDA 510(k) clearance on 1981-01-28, under 510(k) number K803078.

Who is the listed applicant for SIMPLICITY INFUSION PUMP MODEL 2100A?

The FDA 510(k) record lists Critikon Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMPLICITY INFUSION PUMP MODEL 2100A?

The FDA product code for SIMPLICITY INFUSION PUMP MODEL 2100A is FRN.

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Related Devices (Code: FRN)

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Official Source

View on FDA Database →

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

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