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FDA 510(k)

CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A

K-Number: K890703 · 1989-03-17

ApplicantOticon Corp.
Decision Date1989-03-17
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A is the device name listed in this FDA 510(k) record. The listed applicant is Oticon Corp.. It received FDA 510(k) clearance on 1989-03-17 under 510(k) number K890703. 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 CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A?

CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A is a medical device that received FDA 510(k) clearance on 1989-03-17. The listed applicant is Oticon Corp.. The 510(k) number is K890703.

When did CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A receive FDA 510(k) clearance?

CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A received FDA 510(k) clearance on 1989-03-17, under 510(k) number K890703.

Who is the listed applicant for CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A?

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

What is the FDA product code for CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A?

The FDA product code for CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A is ESD.

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Other records listing Oticon Corp. 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.

K963788PRIMOFOCUS COMPACTK932670OTICON MFK923491BTE HEARING AID PERSONIC 425K923388BTE HEARING AID OTICON MODEL: MULTIFOCUS POWERK923490BTE HEARING AID PERSONIC 410K905555A-ZILICONE

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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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