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FDA 510(k)

MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT

K-Number: K962228 · 1996-08-28

ApplicantOtotech Intl., Inc.
Decision Date1996-08-28
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Ototech Intl., Inc.. It received FDA 510(k) clearance on 1996-08-28 under 510(k) number K962228. 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 MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT?

MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT is a medical device that received FDA 510(k) clearance on 1996-08-28. The listed applicant is Ototech Intl., Inc.. The 510(k) number is K962228.

When did MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT receive FDA 510(k) clearance?

MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT received FDA 510(k) clearance on 1996-08-28, under 510(k) number K962228.

Who is the listed applicant for MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT?

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

What is the FDA product code for MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT?

The FDA product code for MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT is ESD.

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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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