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FDA 510(k)

KPE 220 TS, NONSTERILE

K-Number: K914221 · 1991-10-25

ApplicantIpax, Inc.
Decision Date1991-10-25
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KPE 220 TS, NONSTERILE is the device name listed in this FDA 510(k) record. The listed applicant is Ipax, Inc.. It received FDA 510(k) clearance on 1991-10-25 under 510(k) number K914221. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KPE 220 TS, NONSTERILE?

KPE 220 TS, NONSTERILE is a medical device that received FDA 510(k) clearance on 1991-10-25. The listed applicant is Ipax, Inc.. The 510(k) number is K914221.

When did KPE 220 TS, NONSTERILE receive FDA 510(k) clearance?

KPE 220 TS, NONSTERILE received FDA 510(k) clearance on 1991-10-25, under 510(k) number K914221.

Who is the listed applicant for KPE 220 TS, NONSTERILE?

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

What is the FDA product code for KPE 220 TS, NONSTERILE?

The FDA product code for KPE 220 TS, NONSTERILE is HQE.

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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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