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FDA 510(k)

CUSTOM, IN-THE-EAR HEARING AID

K-Number: K821390 · 1982-06-07

ApplicantEar-Tronics, Inc.
Decision Date1982-06-07
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CUSTOM, IN-THE-EAR HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Ear-Tronics, Inc.. It received FDA 510(k) clearance on 1982-06-07 under 510(k) number K821390. 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 CUSTOM, IN-THE-EAR HEARING AID?

CUSTOM, IN-THE-EAR HEARING AID is a medical device that received FDA 510(k) clearance on 1982-06-07. The listed applicant is Ear-Tronics, Inc.. The 510(k) number is K821390.

When did CUSTOM, IN-THE-EAR HEARING AID receive FDA 510(k) clearance?

CUSTOM, IN-THE-EAR HEARING AID received FDA 510(k) clearance on 1982-06-07, under 510(k) number K821390.

Who is the listed applicant for CUSTOM, IN-THE-EAR HEARING AID?

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

What is the FDA product code for CUSTOM, IN-THE-EAR HEARING AID?

The FDA product code for CUSTOM, IN-THE-EAR HEARING AID 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.

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Other records listing Ear-Tronics, 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.

K881299ITE HEARING AID, EAR-TRONICS MODELS: M1-M23

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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