FDA 510(k)

HEALTHMYNE

K-Number: K153289 · 2016-01-15

Decision Date2016-01-15

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HEALTHMYNE is the device name listed in this FDA 510(k) record. The listed applicant is Healthmyne, Inc.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) 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. The listed applicant is Healthmyne, Inc.. The 510(k) number is K153289.

When did HEALTHMYNE receive FDA 510(k) clearance?

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

Who is the listed applicant for HEALTHMYNE?

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

What is the FDA product code for HEALTHMYNE?

The FDA product code for HEALTHMYNE is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

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.