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FDA 510(k)

AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR

K-Number: K964816 · 1997-01-17

ApplicantAudina Hearing Instrument
Decision Date1997-01-17
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR 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 1997-01-17 under 510(k) number K964816. 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 AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR?

AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR is a medical device that received FDA 510(k) clearance on 1997-01-17. The listed applicant is Audina Hearing Instrument. The 510(k) number is K964816.

When did AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR receive FDA 510(k) clearance?

AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR received FDA 510(k) clearance on 1997-01-17, under 510(k) number K964816.

Who is the listed applicant for AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR?

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 AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR?

The FDA product code for AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR is ESD.

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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.

K953960HEARING AID (ALL-IN-THE-EAR)K942236AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)K936190BEHIND THE EAR HEARING AIDK930271BEHIND-THE-EAR HEARING AIDK897024MODEL AUDINA ITE HEATING AIDK897023OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID

View all 8 devices →

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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