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FDA 510(k)

HEALTHMATEFOREVER

K-Number: K121757 · 2012-11-20

ApplicantHealthmate International, LLC
Decision Date2012-11-20
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HEALTHMATEFOREVER is the device name listed in this FDA 510(k) record. The listed applicant is Healthmate International, LLC. It received FDA 510(k) clearance on 2012-11-20 under 510(k) number K121757. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALTHMATEFOREVER?

HEALTHMATEFOREVER is a medical device that received FDA 510(k) clearance on 2012-11-20. The listed applicant is Healthmate International, LLC. The 510(k) number is K121757.

When did HEALTHMATEFOREVER receive FDA 510(k) clearance?

HEALTHMATEFOREVER received FDA 510(k) clearance on 2012-11-20, under 510(k) number K121757.

Who is the listed applicant for HEALTHMATEFOREVER?

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

What is the FDA product code for HEALTHMATEFOREVER?

The FDA product code for HEALTHMATEFOREVER is NUH.

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Related Devices (Code: NUH)

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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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