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FDA 510(k)

BODY-WORN HEARING AID, MODEL 787PP

K-Number: K781595 · 1978-09-27

ApplicantDanavox, Inc.
Decision Date1978-09-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BODY-WORN HEARING AID, MODEL 787PP is the device name listed in this FDA 510(k) record. The listed applicant is Danavox, Inc.. It received FDA 510(k) clearance on 1978-09-27 under 510(k) number K781595. 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-WORN HEARING AID, MODEL 787PP?

BODY-WORN HEARING AID, MODEL 787PP is a medical device that received FDA 510(k) clearance on 1978-09-27. The listed applicant is Danavox, Inc.. The 510(k) number is K781595.

When did BODY-WORN HEARING AID, MODEL 787PP receive FDA 510(k) clearance?

BODY-WORN HEARING AID, MODEL 787PP received FDA 510(k) clearance on 1978-09-27, under 510(k) number K781595.

Who is the listed applicant for BODY-WORN HEARING AID, MODEL 787PP?

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-WORN HEARING AID, MODEL 787PP?

The FDA product code for BODY-WORN HEARING AID, MODEL 787PP 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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