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FDA 510(k)

OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID

K-Number: K897023 · 1990-03-16

ApplicantAudina Hearing Instrument
Decision Date1990-03-16
Product CodeLRB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID is the device name listed in this FDA 510(k) record. The listed applicant is Audina Hearing Instrument. It received FDA 510(k) clearance on 1990-03-16 under 510(k) number K897023. The device is classified under product code LRB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID?

OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID is a medical device that received FDA 510(k) clearance on 1990-03-16. The listed applicant is Audina Hearing Instrument. The 510(k) number is K897023.

When did OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID receive FDA 510(k) clearance?

OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID received FDA 510(k) clearance on 1990-03-16, under 510(k) number K897023.

Who is the listed applicant for OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID?

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

What is the FDA product code for OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID?

The FDA product code for OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID is LRB.

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Other records listing Audina Hearing Instrument 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.

K964816AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EARK953960HEARING AID (ALL-IN-THE-EAR)K942236AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)K936190BEHIND THE EAR HEARING AIDK930271BEHIND-THE-EAR HEARING AIDK897024MODEL AUDINA ITE HEATING AID

View all 8 devices →

Related Devices (Code: LRB)

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.

K974219FACEPLATE ASSEMBLYFinetone Hearing InstrumentsK961593INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDSSegi Hearing Aid Co.K942722MODULE PROGRAMElectone, Inc.K942236AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)Audina Hearing InstrumentK935048ARTISAN PROGRAMMER & HEARING AIDTelex Communications, Inc.K933046SILVER L MODULE, ITEElectone, 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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