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FDA 510(k)

HEARTECH MODEL IN TECH

K-Number: K854315 · 1986-01-21

ApplicantHearing Tech, Inc.
Decision Date1986-01-21
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARTECH MODEL IN 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 1986-01-21 under 510(k) number K854315. 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 HEARTECH MODEL IN TECH?

HEARTECH MODEL IN TECH is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Hearing Tech, Inc.. The 510(k) number is K854315.

When did HEARTECH MODEL IN TECH receive FDA 510(k) clearance?

HEARTECH MODEL IN TECH received FDA 510(k) clearance on 1986-01-21, under 510(k) number K854315.

Who is the listed applicant for HEARTECH MODEL IN 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 HEARTECH MODEL IN TECH?

The FDA product code for HEARTECH MODEL IN 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.

K941587HEARING TECHK924712ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEMK905680543 SERIES BTEK903295ESCORT ITCK903023HERITAGE III (HTC) ITC TYPE HEARING AIDK870723HEARTECH HFX, 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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