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FDA 510(k)

HEARING TECH

K-Number: K941587 · 1994-06-24

ApplicantHearing Tech, Inc.
Decision Date1994-06-24
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARING TECH is the device name listed in this FDA 510(k) record. The listed applicant is Hearing Tech, Inc.. It received FDA 510(k) clearance on 1994-06-24 under 510(k) number K941587. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARING TECH?

HEARING TECH is a medical device that received FDA 510(k) clearance on 1994-06-24. The listed applicant is Hearing Tech, Inc.. The 510(k) number is K941587.

When did HEARING TECH receive FDA 510(k) clearance?

HEARING TECH received FDA 510(k) clearance on 1994-06-24, under 510(k) number K941587.

Who is the listed applicant for HEARING TECH?

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

What is the FDA product code for HEARING TECH?

The FDA product code for HEARING TECH is ESD.

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 Hearing Tech, 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.

K924712ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEMK905680543 SERIES BTEK903295ESCORT ITCK903023HERITAGE III (HTC) ITC TYPE HEARING AIDK870723HEARTECH HFX, HEARING AIDK870350ESCORT EC CUSTOM IN-THE-EAR HEARING AID

View all 11 devices →

Related Devices (Code: ESD)

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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, 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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