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FDA 510(k)

DAHLBERG HEARING AID MODEL MEL

K-Number: K801115 · 1980-05-28

ApplicantDahlberg Electronics, Inc.
Decision Date1980-05-28
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DAHLBERG HEARING AID MODEL MEL 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 1980-05-28 under 510(k) number K801115. 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 DAHLBERG HEARING AID MODEL MEL?

DAHLBERG HEARING AID MODEL MEL is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Dahlberg Electronics, Inc.. The 510(k) number is K801115.

When did DAHLBERG HEARING AID MODEL MEL receive FDA 510(k) clearance?

DAHLBERG HEARING AID MODEL MEL received FDA 510(k) clearance on 1980-05-28, under 510(k) number K801115.

Who is the listed applicant for DAHLBERG HEARING AID MODEL MEL?

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 DAHLBERG HEARING AID MODEL MEL?

The FDA product code for DAHLBERG HEARING AID MODEL MEL 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.

K896157DAHLBERG MODEL LH BEHIND-THE-EAR HEARING AIDK896158DAHLBERG MODEL LA BEHIND-THE-EAR HEARING AIDK896159DAHLBERG MODEL LP BEHIND-THE-EAR HEARING AIDK881417DAHLBERG MODEL GP BODY AIDK881612DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AIDK874831AUDIOTONE MODEL A2000 BEHIND-THE-EAR HEARING AID

View all 31 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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