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FDA 510(k)

MULTIFLEX TINNITUS TECHNOLOGY

K-Number: K122876 · 2012-10-31

ApplicantStarkey Laboratories
Decision Date2012-10-31
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MULTIFLEX TINNITUS TECHNOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Starkey Laboratories. It received FDA 510(k) clearance on 2012-10-31 under 510(k) number K122876. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIFLEX TINNITUS TECHNOLOGY?

MULTIFLEX TINNITUS TECHNOLOGY is a medical device that received FDA 510(k) clearance on 2012-10-31. The listed applicant is Starkey Laboratories. The 510(k) number is K122876.

When did MULTIFLEX TINNITUS TECHNOLOGY receive FDA 510(k) clearance?

MULTIFLEX TINNITUS TECHNOLOGY received FDA 510(k) clearance on 2012-10-31, under 510(k) number K122876.

Who is the listed applicant for MULTIFLEX TINNITUS TECHNOLOGY?

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

What is the FDA product code for MULTIFLEX TINNITUS TECHNOLOGY?

The FDA product code for MULTIFLEX TINNITUS TECHNOLOGY is KLW.

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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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