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FDA 510(k)

HEARING AID, MODEL GB

K-Number: K782121 · 1979-01-22

ApplicantDahlberg Electronics, Inc.
Decision Date1979-01-22
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARING AID, MODEL GB is the device name listed in this FDA 510(k) record. The listed applicant is Dahlberg Electronics, Inc.. It received FDA 510(k) clearance on 1979-01-22 under 510(k) number K782121. 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 HEARING AID, MODEL GB?

HEARING AID, MODEL GB is a medical device that received FDA 510(k) clearance on 1979-01-22. The listed applicant is Dahlberg Electronics, Inc.. The 510(k) number is K782121.

When did HEARING AID, MODEL GB receive FDA 510(k) clearance?

HEARING AID, MODEL GB received FDA 510(k) clearance on 1979-01-22, under 510(k) number K782121.

Who is the listed applicant for HEARING AID, MODEL GB?

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

What is the FDA product code for HEARING AID, MODEL GB?

The FDA product code for HEARING AID, MODEL GB is ESD.

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Other records listing Dahlberg Electronics, 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.

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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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