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FDA 510(k)

BEHIND-THE-EAR MODEL 115

K-Number: K812937 · 1981-11-06

ApplicantDanavox, Inc.
Decision Date1981-11-06
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BEHIND-THE-EAR MODEL 115 is the device name listed in this FDA 510(k) record. The listed applicant is Danavox, Inc.. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K812937. 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 BEHIND-THE-EAR MODEL 115?

BEHIND-THE-EAR MODEL 115 is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Danavox, Inc.. The 510(k) number is K812937.

When did BEHIND-THE-EAR MODEL 115 receive FDA 510(k) clearance?

BEHIND-THE-EAR MODEL 115 received FDA 510(k) clearance on 1981-11-06, under 510(k) number K812937.

Who is the listed applicant for BEHIND-THE-EAR MODEL 115?

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 BEHIND-THE-EAR MODEL 115?

The FDA product code for BEHIND-THE-EAR MODEL 115 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-IK851069BODY TYPE HEARING AID 107SK843791BEHIND-THE-EAR 123 VTHK833486IN-THE-EAR HEARING AID MODELK832326BEHIND-THE-EAR #123 AGCIK832751BEHIND-THE-EAR SERIES 125

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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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