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FDA 510(k)

EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE

K-Number: K093715 · 2010-12-22

ApplicantMagnatone Hearing Aid Corp. Dba Persona Medical
Decision Date2010-12-22
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Magnatone Hearing Aid Corp. Dba Persona Medical. It received FDA 510(k) clearance on 2010-12-22 under 510(k) number K093715. 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 EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE?

EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE is a medical device that received FDA 510(k) clearance on 2010-12-22. The listed applicant is Magnatone Hearing Aid Corp. Dba Persona Medical. The 510(k) number is K093715.

When did EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE receive FDA 510(k) clearance?

EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE received FDA 510(k) clearance on 2010-12-22, under 510(k) number K093715.

Who is the listed applicant for EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE?

The FDA 510(k) record lists Magnatone Hearing Aid Corp. Dba Persona Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE?

The FDA product code for EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE 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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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

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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