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FDA 510(k)

MICRO-TECH TRU CANAL

K-Number: K934149 · 1993-12-27

ApplicantMicro-Ear Technology, Inc.
Decision Date1993-12-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MICRO-TECH TRU CANAL is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Ear Technology, Inc.. It received FDA 510(k) clearance on 1993-12-27 under 510(k) number K934149. 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 MICRO-TECH TRU CANAL?

MICRO-TECH TRU CANAL is a medical device that received FDA 510(k) clearance on 1993-12-27. The listed applicant is Micro-Ear Technology, Inc.. The 510(k) number is K934149.

When did MICRO-TECH TRU CANAL receive FDA 510(k) clearance?

MICRO-TECH TRU CANAL received FDA 510(k) clearance on 1993-12-27, under 510(k) number K934149.

Who is the listed applicant for MICRO-TECH TRU CANAL?

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

What is the FDA product code for MICRO-TECH TRU CANAL?

The FDA product code for MICRO-TECH TRU CANAL is ESD.

Related Clinical Trials

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Other records listing Micro-Ear Technology, 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.

K041302REFUGE SOUND GENERATORK972431MERIDIAN DSPK970880POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIANK964657SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF

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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