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FDA 510(k)

REFUGE SOUND GENERATOR

K-Number: K041302 · 2004-07-01

ApplicantMicro-Ear Technology, Inc.
Decision Date2004-07-01
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

REFUGE SOUND GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Ear Technology, Inc.. It received FDA 510(k) clearance on 2004-07-01 under 510(k) number K041302. 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 REFUGE SOUND GENERATOR?

REFUGE SOUND GENERATOR is a medical device that received FDA 510(k) clearance on 2004-07-01. The listed applicant is Micro-Ear Technology, Inc.. The 510(k) number is K041302.

When did REFUGE SOUND GENERATOR receive FDA 510(k) clearance?

REFUGE SOUND GENERATOR received FDA 510(k) clearance on 2004-07-01, under 510(k) number K041302.

Who is the listed applicant for REFUGE SOUND GENERATOR?

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

What is the FDA product code for REFUGE SOUND GENERATOR?

The FDA product code for REFUGE SOUND GENERATOR is KLW.

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Other records listing Micro-Ear Technology, 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.

K972431MERIDIAN DSPK970880POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIANK964657SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HFK934149MICRO-TECH TRU CANAL

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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