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FDA 510(k)

CRESCENT TINNITUS RETAINING SOUND GENERATOR

K-Number: K030180 · 2003-09-17

ApplicantStarkey Laboratories, Inc.
Decision Date2003-09-17
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CRESCENT TINNITUS RETAINING SOUND GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Starkey Laboratories, Inc.. It received FDA 510(k) clearance on 2003-09-17 under 510(k) number K030180. 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 CRESCENT TINNITUS RETAINING SOUND GENERATOR?

CRESCENT TINNITUS RETAINING SOUND GENERATOR is a medical device that received FDA 510(k) clearance on 2003-09-17. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K030180.

When did CRESCENT TINNITUS RETAINING SOUND GENERATOR receive FDA 510(k) clearance?

CRESCENT TINNITUS RETAINING SOUND GENERATOR received FDA 510(k) clearance on 2003-09-17, under 510(k) number K030180.

Who is the listed applicant for CRESCENT TINNITUS RETAINING SOUND GENERATOR?

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

What is the FDA product code for CRESCENT TINNITUS RETAINING SOUND GENERATOR?

The FDA product code for CRESCENT TINNITUS RETAINING SOUND GENERATOR is KLW.

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Related Devices (Code: KLW)

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.

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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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