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FDA 510(k)

HP-1 (HEALTHPAX)

K-Number: K883812 · 1988-11-28

ApplicantHealthdirections, Inc.
Decision Date1988-11-28
Product CodeQJQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HP-1 (HEALTHPAX) is the device name listed in this FDA 510(k) record. The listed applicant is Healthdirections, Inc.. It received FDA 510(k) clearance on 1988-11-28 under 510(k) number K883812. The device is classified under product code QJQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HP-1 (HEALTHPAX)?

HP-1 (HEALTHPAX) is a medical device that received FDA 510(k) clearance on 1988-11-28. The listed applicant is Healthdirections, Inc.. The 510(k) number is K883812.

When did HP-1 (HEALTHPAX) receive FDA 510(k) clearance?

HP-1 (HEALTHPAX) received FDA 510(k) clearance on 1988-11-28, under 510(k) number K883812.

Who is the listed applicant for HP-1 (HEALTHPAX)?

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

What is the FDA product code for HP-1 (HEALTHPAX)?

The FDA product code for HP-1 (HEALTHPAX) is QJQ.

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Related Devices (Code: QJQ)

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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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