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FDA 510(k)

HEARING AID, UNITRON UT1

K-Number: K833614 · 1983-11-21

ApplicantUnitron Industries, Inc.
Decision Date1983-11-21
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARING AID, UNITRON UT1 is the device name listed in this FDA 510(k) record. The listed applicant is Unitron Industries, Inc.. It received FDA 510(k) clearance on 1983-11-21 under 510(k) number K833614. 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 AID, UNITRON UT1?

HEARING AID, UNITRON UT1 is a medical device that received FDA 510(k) clearance on 1983-11-21. The listed applicant is Unitron Industries, Inc.. The 510(k) number is K833614.

When did HEARING AID, UNITRON UT1 receive FDA 510(k) clearance?

HEARING AID, UNITRON UT1 received FDA 510(k) clearance on 1983-11-21, under 510(k) number K833614.

Who is the listed applicant for HEARING AID, UNITRON UT1?

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

What is the FDA product code for HEARING AID, UNITRON UT1?

The FDA product code for HEARING AID, UNITRON UT1 is ESD.

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Other records listing Unitron Industries, Inc. as applicant

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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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