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FDA 510(k)

KPE 230 AM

K-Number: K914172 · 1991-10-25

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

Device Summary

KPE 230 AM 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 K914172. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KPE 230 AM?

KPE 230 AM 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 K914172.

When did KPE 230 AM receive FDA 510(k) clearance?

KPE 230 AM received FDA 510(k) clearance on 1991-10-25, under 510(k) number K914172.

Who is the listed applicant for KPE 230 AM?

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 230 AM?

The FDA product code for KPE 230 AM is HQC.

Other records listing Ipax, Inc. as applicant

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Related Devices (Code: HQC)

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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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