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FDA 510(k)

HEALTHMYNE

K-Number: K153289 · 2016-01-15

ApplicantHealthmyne, Inc.
Decision Date2016-01-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HEALTHMYNE is a medical device manufactured by Healthmyne, Inc.. It received FDA 510(k) clearance on 2016-01-15 under approval number K153289. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALTHMYNE?

HEALTHMYNE is a medical device that received FDA 510(k) clearance on 2016-01-15. It is manufactured by Healthmyne, Inc.. The 510(k) number is K153289.

When was HEALTHMYNE approved by the FDA?

HEALTHMYNE received FDA 510(k) clearance on 2016-01-15, under approval number K153289.

What company makes HEALTHMYNE?

HEALTHMYNE is manufactured by Healthmyne, Inc..

What is the FDA product code for HEALTHMYNE?

The FDA product code for HEALTHMYNE is LLZ.

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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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