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FDA 510(k)

FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA

K-Number: K894176 · 1989-11-03

ApplicantPrecision Hearing Instruments
Decision Date1989-11-03
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA is the device name listed in this FDA 510(k) record. The listed applicant is Precision Hearing Instruments. It received FDA 510(k) clearance on 1989-11-03 under 510(k) number K894176. 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 FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA?

FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA is a medical device that received FDA 510(k) clearance on 1989-11-03. The listed applicant is Precision Hearing Instruments. The 510(k) number is K894176.

When did FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA receive FDA 510(k) clearance?

FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA received FDA 510(k) clearance on 1989-11-03, under 510(k) number K894176.

Who is the listed applicant for FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA?

The FDA 510(k) record lists Precision Hearing Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA?

The FDA product code for FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA 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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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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