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FDA 510(k)

PHONAK TINNITUS BALANCE

K-Number: K123450 · 2013-02-11

ApplicantPhonak, LLC
Decision Date2013-02-11
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PHONAK TINNITUS BALANCE is the device name listed in this FDA 510(k) record. The listed applicant is Phonak, LLC. It received FDA 510(k) clearance on 2013-02-11 under 510(k) number K123450. 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 PHONAK TINNITUS BALANCE?

PHONAK TINNITUS BALANCE is a medical device that received FDA 510(k) clearance on 2013-02-11. The listed applicant is Phonak, LLC. The 510(k) number is K123450.

When did PHONAK TINNITUS BALANCE receive FDA 510(k) clearance?

PHONAK TINNITUS BALANCE received FDA 510(k) clearance on 2013-02-11, under 510(k) number K123450.

Who is the listed applicant for PHONAK TINNITUS BALANCE?

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

What is the FDA product code for PHONAK TINNITUS BALANCE?

The FDA product code for PHONAK TINNITUS BALANCE is KLW.

Related Clinical Trials

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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Other records listing Phonak, LLC as applicant

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.

K130790LYRIC2

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.

K260413Levo Gen 2 Tinnitus Therapy SystemLevo Medical CorporationK260614Tinnitus TherapySivantos GmbHK233435Peace N Quiet (0.7.0)Pnq HealthK223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity ABK221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbH

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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