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FDA 510(k)

MODEL H 37E

K-Number: K823468 · 1982-12-03

ApplicantMarcon Hearing Instruments, Inc.
Decision Date1982-12-03
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL H 37E 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 1982-12-03 under 510(k) number K823468. 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 H 37E?

MODEL H 37E is a medical device that received FDA 510(k) clearance on 1982-12-03. The listed applicant is Marcon Hearing Instruments, Inc.. The 510(k) number is K823468.

When did MODEL H 37E receive FDA 510(k) clearance?

MODEL H 37E received FDA 510(k) clearance on 1982-12-03, under 510(k) number K823468.

Who is the listed applicant for MODEL H 37E?

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 H 37E?

The FDA product code for MODEL H 37E 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.

K821042MODEL IM9K791745MODEL H44-80 BEHIND THE EAR HEARINGK791126MODEL CE-DM-II HEARING INSTRUMENTK790870MODEL H63, BEHIND-THE-EARK790779MODEL H39C-BEHING-THE-EAR HEARING INSTRUK790726BEHIND-THE-EAR HEARING INSTRUMENT, H54

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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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