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FDA 510(k)

MODEL IM9

K-Number: K821042 · 1982-05-05

ApplicantMarcon Hearing Instruments, Inc.
Decision Date1982-05-05
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL IM9 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 1982-05-05 under 510(k) number K821042. 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 IM9?

MODEL IM9 is a medical device that received FDA 510(k) clearance on 1982-05-05. The listed applicant is Marcon Hearing Instruments, Inc.. The 510(k) number is K821042.

When did MODEL IM9 receive FDA 510(k) clearance?

MODEL IM9 received FDA 510(k) clearance on 1982-05-05, under 510(k) number K821042.

Who is the listed applicant for MODEL IM9?

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 IM9?

The FDA product code for MODEL IM9 is ESD.

Related Clinical Trials

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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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 37EK791745MODEL 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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