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FDA 510(k)

EARETTE HEARING AID SEARS #8054

K-Number: K810379 · 1981-03-04

ApplicantOticon Corp.
Decision Date1981-03-04
Product CodeFSD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EARETTE HEARING AID SEARS #8054 is the device name listed in this FDA 510(k) record. The listed applicant is Oticon Corp.. It received FDA 510(k) clearance on 1981-03-04 under 510(k) number K810379. The device is classified under product code FSD. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EARETTE HEARING AID SEARS #8054?

EARETTE HEARING AID SEARS #8054 is a medical device that received FDA 510(k) clearance on 1981-03-04. The listed applicant is Oticon Corp.. The 510(k) number is K810379.

When did EARETTE HEARING AID SEARS #8054 receive FDA 510(k) clearance?

EARETTE HEARING AID SEARS #8054 received FDA 510(k) clearance on 1981-03-04, under 510(k) number K810379.

Who is the listed applicant for EARETTE HEARING AID SEARS #8054?

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 EARETTE HEARING AID SEARS #8054?

The FDA product code for EARETTE HEARING AID SEARS #8054 is FSD.

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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: FSD)

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.

K892379THE POUCH GROIN & ABDOMINAL STRESS AIDKuhn IndustriesK822817DOCE ALL-IN-THE-EAR AIDFidelty Hearing Instruments, Inc.K770162MATERNITY SUPPORTERR.G. MooreK760772DISPOSABLE ABDOMINAL BINDERTecnol New Jersey Wound Care, 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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