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FDA 510(k)

MODEL H58-BEHIND-THE-EAR HEARING INSTR.

K-Number: K790697 · 1979-05-01

ApplicantMarcon Hearing Instruments, Inc.
Decision Date1979-05-01
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL H58-BEHIND-THE-EAR HEARING INSTR. is the device name listed in this FDA 510(k) record. The listed applicant is Marcon Hearing Instruments, Inc.. It received FDA 510(k) clearance on 1979-05-01 under 510(k) number K790697. 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 MODEL H58-BEHIND-THE-EAR HEARING INSTR.?

MODEL H58-BEHIND-THE-EAR HEARING INSTR. is a medical device that received FDA 510(k) clearance on 1979-05-01. The listed applicant is Marcon Hearing Instruments, Inc.. The 510(k) number is K790697.

When did MODEL H58-BEHIND-THE-EAR HEARING INSTR. receive FDA 510(k) clearance?

MODEL H58-BEHIND-THE-EAR HEARING INSTR. received FDA 510(k) clearance on 1979-05-01, under 510(k) number K790697.

Who is the listed applicant for MODEL H58-BEHIND-THE-EAR HEARING INSTR.?

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

What is the FDA product code for MODEL H58-BEHIND-THE-EAR HEARING INSTR.?

The FDA product code for MODEL H58-BEHIND-THE-EAR HEARING INSTR. is ESD.

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Other records listing Marcon Hearing Instruments, 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.

K823468MODEL H 37EK821042MODEL IM9K791745MODEL H44-80 BEHIND THE EAR HEARINGK791126MODEL CE-DM-II HEARING INSTRUMENTK790870MODEL H63, BEHIND-THE-EARK790779MODEL H39C-BEHING-THE-EAR HEARING INSTRU

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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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