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FDA 510(k)

POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN

K-Number: K970880 · 1997-06-06

ApplicantMicro-Ear Technology, Inc.
Decision Date1997-06-06
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN 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 1997-06-06 under 510(k) number K970880. 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 POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN?

POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN is a medical device that received FDA 510(k) clearance on 1997-06-06. The listed applicant is Micro-Ear Technology, Inc.. The 510(k) number is K970880.

When did POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN receive FDA 510(k) clearance?

POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN received FDA 510(k) clearance on 1997-06-06, under 510(k) number K970880.

Who is the listed applicant for POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN?

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 POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN?

The FDA product code for POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN is ESD.

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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 DSPK964657SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HFK934149MICRO-TECH TRU CANAL

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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