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FDA 510(k)

SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF

K-Number: K964657 · 1997-02-11

ApplicantMicro-Ear Technology, Inc.
Decision Date1997-02-11
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF 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 1997-02-11 under 510(k) number K964657. 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 SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF?

SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF is a medical device that received FDA 510(k) clearance on 1997-02-11. The listed applicant is Micro-Ear Technology, Inc.. The 510(k) number is K964657.

When did SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF receive FDA 510(k) clearance?

SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF received FDA 510(k) clearance on 1997-02-11, under 510(k) number K964657.

Who is the listed applicant for SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF?

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 SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF?

The FDA product code for SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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, MERIDIANK934149MICRO-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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