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FDA 510(k)

TRANQUIL TRI-BTE

K-Number: K061459 · 2006-06-30

ApplicantGeneral Hearing Instruments, Inc.
Decision Date2006-06-30
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TRANQUIL TRI-BTE is the device name listed in this FDA 510(k) record. The listed applicant is General Hearing Instruments, Inc.. It received FDA 510(k) clearance on 2006-06-30 under 510(k) number K061459. 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 TRANQUIL TRI-BTE?

TRANQUIL TRI-BTE is a medical device that received FDA 510(k) clearance on 2006-06-30. The listed applicant is General Hearing Instruments, Inc.. The 510(k) number is K061459.

When did TRANQUIL TRI-BTE receive FDA 510(k) clearance?

TRANQUIL TRI-BTE received FDA 510(k) clearance on 2006-06-30, under 510(k) number K061459.

Who is the listed applicant for TRANQUIL TRI-BTE?

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

What is the FDA product code for TRANQUIL TRI-BTE?

The FDA product code for TRANQUIL TRI-BTE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing General Hearing Instruments, 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.

K974751TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CICK971399AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CICK943144AURIS CICK850123IN-TH-EAR HEARING AID

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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