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FDA 510(k)

OMNI

K-Number: K811158 · 1981-05-27

ApplicantOmni Hearing Systems
Decision Date1981-05-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OMNI is the device name listed in this FDA 510(k) record. The listed applicant is Omni Hearing Systems. It received FDA 510(k) clearance on 1981-05-27 under 510(k) number K811158. 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 OMNI?

OMNI is a medical device that received FDA 510(k) clearance on 1981-05-27. The listed applicant is Omni Hearing Systems. The 510(k) number is K811158.

When did OMNI receive FDA 510(k) clearance?

OMNI received FDA 510(k) clearance on 1981-05-27, under 510(k) number K811158.

Who is the listed applicant for OMNI?

The FDA 510(k) record lists Omni Hearing Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNI?

The FDA product code for OMNI is ESD.

Other records listing Omni Hearing Systems 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.

K843921IN THE CANAL HEARING AID RC, REDICANALK833333IN THE EAR HEARING AID OMNI 100K833334BEHIND THE EAR ASP-BBK833451TEL-STAR NUWAY & GENERIC E ASP-BPK830459BEHIND THE EAR HEARING AID OMNI #OSK823178TEL-STAR NU-WAY & GENERIC E

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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