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FDA 510(k)

PE-01 ELECTRONIC INFUSION PUMP

K-Number: K812898 · 1981-12-02

ApplicantEgnell, Inc.
Decision Date1981-12-02
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PE-01 ELECTRONIC INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Egnell, Inc.. It received FDA 510(k) clearance on 1981-12-02 under 510(k) number K812898. 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 PE-01 ELECTRONIC INFUSION PUMP?

PE-01 ELECTRONIC INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1981-12-02. The listed applicant is Egnell, Inc.. The 510(k) number is K812898.

When did PE-01 ELECTRONIC INFUSION PUMP receive FDA 510(k) clearance?

PE-01 ELECTRONIC INFUSION PUMP received FDA 510(k) clearance on 1981-12-02, under 510(k) number K812898.

Who is the listed applicant for PE-01 ELECTRONIC INFUSION PUMP?

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

What is the FDA product code for PE-01 ELECTRONIC INFUSION PUMP?

The FDA product code for PE-01 ELECTRONIC INFUSION PUMP is FRN.

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Other records listing Egnell, Inc. as applicant

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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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