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FDA 510(k)

OTICON

K-Number: K821325 · 1982-06-07

ApplicantOticon Corp.
Decision Date1982-06-07
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTICON is the device name listed in this FDA 510(k) record. The listed applicant is Oticon Corp.. It received FDA 510(k) clearance on 1982-06-07 under 510(k) number K821325. 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 OTICON?

OTICON is a medical device that received FDA 510(k) clearance on 1982-06-07. The listed applicant is Oticon Corp.. The 510(k) number is K821325.

When did OTICON receive FDA 510(k) clearance?

OTICON received FDA 510(k) clearance on 1982-06-07, under 510(k) number K821325.

Who is the listed applicant for OTICON?

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 OTICON?

The FDA product code for OTICON 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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