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FDA 510(k)

FACEPLATE ASSEMBLY

K-Number: K974219 · 1998-02-20

ApplicantFinetone Hearing Instruments
Decision Date1998-02-20
Product CodeLRB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FACEPLATE ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Finetone Hearing Instruments. It received FDA 510(k) clearance on 1998-02-20 under 510(k) number K974219. The device is classified under product code LRB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FACEPLATE ASSEMBLY?

FACEPLATE ASSEMBLY is a medical device that received FDA 510(k) clearance on 1998-02-20. The listed applicant is Finetone Hearing Instruments. The 510(k) number is K974219.

When did FACEPLATE ASSEMBLY receive FDA 510(k) clearance?

FACEPLATE ASSEMBLY received FDA 510(k) clearance on 1998-02-20, under 510(k) number K974219.

Who is the listed applicant for FACEPLATE ASSEMBLY?

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

What is the FDA product code for FACEPLATE ASSEMBLY?

The FDA product code for FACEPLATE ASSEMBLY is LRB.

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 Finetone Hearing Instruments 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.

K955692FINETONE FSC,K945780FINETONE DISCEET CANALK940164SUPER-SILK830960CUSTOM IN-THE-EAR HEARING AID

Related Devices (Code: LRB)

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.

K961593INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDSSegi Hearing Aid Co.K942722MODULE PROGRAMElectone, Inc.K942236AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)Audina Hearing InstrumentK935048ARTISAN PROGRAMMER & HEARING AIDTelex Communications, Inc.K933039GOLD L MODULE, ITEElectone, Inc.K933046SILVER L MODULE, ITEElectone, Inc.

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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