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FDA 510(k)

BEHIND THE EAR HEARING AID OMNI #OS

K-Number: K830459 · 1983-03-07

ApplicantOmni Hearing Systems
Decision Date1983-03-07
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BEHIND THE EAR HEARING AID OMNI #OS 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 1983-03-07 under 510(k) number K830459. 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 BEHIND THE EAR HEARING AID OMNI #OS?

BEHIND THE EAR HEARING AID OMNI #OS is a medical device that received FDA 510(k) clearance on 1983-03-07. The listed applicant is Omni Hearing Systems. The 510(k) number is K830459.

When did BEHIND THE EAR HEARING AID OMNI #OS receive FDA 510(k) clearance?

BEHIND THE EAR HEARING AID OMNI #OS received FDA 510(k) clearance on 1983-03-07, under 510(k) number K830459.

Who is the listed applicant for BEHIND THE EAR HEARING AID OMNI #OS?

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 BEHIND THE EAR HEARING AID OMNI #OS?

The FDA product code for BEHIND THE EAR HEARING AID OMNI #OS is ESD.

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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-BPK823178TEL-STAR NU-WAY & GENERIC EK811158OMNI

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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