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FDA 510(k)

MODEL H63, BEHIND-THE-EAR

K-Number: K790870 · 1979-07-05

ApplicantMarcon Hearing Instruments, Inc.
Decision Date1979-07-05
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL H63, BEHIND-THE-EAR 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 1979-07-05 under 510(k) number K790870. 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 H63, BEHIND-THE-EAR?

MODEL H63, BEHIND-THE-EAR is a medical device that received FDA 510(k) clearance on 1979-07-05. The listed applicant is Marcon Hearing Instruments, Inc.. The 510(k) number is K790870.

When did MODEL H63, BEHIND-THE-EAR receive FDA 510(k) clearance?

MODEL H63, BEHIND-THE-EAR received FDA 510(k) clearance on 1979-07-05, under 510(k) number K790870.

Who is the listed applicant for MODEL H63, BEHIND-THE-EAR?

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 H63, BEHIND-THE-EAR?

The FDA product code for MODEL H63, BEHIND-THE-EAR 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 INSTRUMENTK790779MODEL H39C-BEHING-THE-EAR HEARING INSTRUK790700BEHIND-THE-EAR HEARING INSTRUMENT, H56

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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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