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FDA 510(k)

INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS

K-Number: K961593 · 1996-11-07

ApplicantSegi Hearing Aid Co.
Decision Date1996-11-07
Product CodeLRB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS is the device name listed in this FDA 510(k) record. The listed applicant is Segi Hearing Aid Co.. It received FDA 510(k) clearance on 1996-11-07 under 510(k) number K961593. 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 INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS?

INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS is a medical device that received FDA 510(k) clearance on 1996-11-07. The listed applicant is Segi Hearing Aid Co.. The 510(k) number is K961593.

When did INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS receive FDA 510(k) clearance?

INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS received FDA 510(k) clearance on 1996-11-07, under 510(k) number K961593.

Who is the listed applicant for INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS?

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

What is the FDA product code for INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS?

The FDA product code for INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS 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

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.

K974219FACEPLATE ASSEMBLYFinetone Hearing InstrumentsK942722MODULE 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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