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FDA 510(k)

OMNITON MT80-A BODY HEARING AID

K-Number: K800779 · 1980-06-04

ApplicantBosch Hearing Instruments, Inc.
Decision Date1980-06-04
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OMNITON MT80-A BODY HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Bosch Hearing Instruments, Inc.. It received FDA 510(k) clearance on 1980-06-04 under 510(k) number K800779. 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 OMNITON MT80-A BODY HEARING AID?

OMNITON MT80-A BODY HEARING AID is a medical device that received FDA 510(k) clearance on 1980-06-04. The listed applicant is Bosch Hearing Instruments, Inc.. The 510(k) number is K800779.

When did OMNITON MT80-A BODY HEARING AID receive FDA 510(k) clearance?

OMNITON MT80-A BODY HEARING AID received FDA 510(k) clearance on 1980-06-04, under 510(k) number K800779.

Who is the listed applicant for OMNITON MT80-A BODY HEARING AID?

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

What is the FDA product code for OMNITON MT80-A BODY HEARING AID?

The FDA product code for OMNITON MT80-A BODY HEARING AID 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 Bosch 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.

K840571EKG 503AK840569EKG 501 AK840574EBM-500K822579BOSCH STAR 66F-SP HEARING AIDK820041BOSCH TOP STAR IIIK810347BOSCH STAR 66F SUPER EARLEVEL AID

View all 7 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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