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FDA 510(k)

BODY TYPE HEARING AID 107S

K-Number: K851069 · 1985-06-05

ApplicantDanavox, Inc.
Decision Date1985-06-05
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BODY TYPE HEARING AID 107S is the device name listed in this FDA 510(k) record. The listed applicant is Danavox, Inc.. It received FDA 510(k) clearance on 1985-06-05 under 510(k) number K851069. 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 BODY TYPE HEARING AID 107S?

BODY TYPE HEARING AID 107S is a medical device that received FDA 510(k) clearance on 1985-06-05. The listed applicant is Danavox, Inc.. The 510(k) number is K851069.

When did BODY TYPE HEARING AID 107S receive FDA 510(k) clearance?

BODY TYPE HEARING AID 107S received FDA 510(k) clearance on 1985-06-05, under 510(k) number K851069.

Who is the listed applicant for BODY TYPE HEARING AID 107S?

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

What is the FDA product code for BODY TYPE HEARING AID 107S?

The FDA product code for BODY TYPE HEARING AID 107S is ESD.

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Other records listing Danavox, Inc. 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.

K940608155 PP AGC-IK843791BEHIND-THE-EAR 123 VTHK833486IN-THE-EAR HEARING AID MODELK832326BEHIND-THE-EAR #123 AGCIK832751BEHIND-THE-EAR SERIES 125K823073101M IN-THE-EAR

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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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