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FDA 510(k)

AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY)

K-Number: K963047 · 1996-09-10

ApplicantFenwick Hearing Instruments
Decision Date1996-09-10
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY) is the device name listed in this FDA 510(k) record. The listed applicant is Fenwick Hearing Instruments. It received FDA 510(k) clearance on 1996-09-10 under 510(k) number K963047. 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 AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY)?

AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY) is a medical device that received FDA 510(k) clearance on 1996-09-10. The listed applicant is Fenwick Hearing Instruments. The 510(k) number is K963047.

When did AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY) receive FDA 510(k) clearance?

AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY) received FDA 510(k) clearance on 1996-09-10, under 510(k) number K963047.

Who is the listed applicant for AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY)?

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

What is the FDA product code for AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY)?

The FDA product code for AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY) 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 Fenwick 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.

K913366IN-THE-EAR HEARING AIDS

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

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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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