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FDA 510(k)

Multiflex Tinnitus Technology

K-Number: K201370 · 2020-06-19

ApplicantStarkey Laboratories, Inc.
Decision Date2020-06-19
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Multiflex Tinnitus Technology is a medical device manufactured by Starkey Laboratories, Inc.. It received FDA 510(k) clearance on 2020-06-19 under approval number K201370. 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 2020-06-19. It is manufactured by Starkey Laboratories, Inc.. The 510(k) number is K201370.

When was Multiflex Tinnitus Technology approved by the FDA?

Multiflex Tinnitus Technology received FDA 510(k) clearance on 2020-06-19, under approval number K201370.

What company makes Multiflex Tinnitus Technology?

Multiflex Tinnitus Technology is manufactured by Starkey Laboratories, Inc..

What is the FDA product code for Multiflex Tinnitus Technology?

The FDA product code for Multiflex Tinnitus Technology is KLW.

Related Devices (Code: KLW)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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