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FDA 510(k)

AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S

K-Number: K130417 · 2013-09-12

ApplicantAudifon-USA, Inc.
Decision Date2013-09-12
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S is the device name listed in this FDA 510(k) record. The listed applicant is Audifon-USA, Inc.. It received FDA 510(k) clearance on 2013-09-12 under 510(k) number K130417. 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 AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S?

AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S is a medical device that received FDA 510(k) clearance on 2013-09-12. The listed applicant is Audifon-USA, Inc.. The 510(k) number is K130417.

When did AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S receive FDA 510(k) clearance?

AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S received FDA 510(k) clearance on 2013-09-12, under 510(k) number K130417.

Who is the listed applicant for AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S?

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

What is the FDA product code for AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S?

The FDA product code for AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S is KLW.

Related Clinical Trials

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Other records listing Audifon-USA, Inc. 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.

K130514AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRTK121793AN EVO 1, CS EVO 1, CONTACT MINI, APOLLONK083488JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT

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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