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FDA 510(k)

TEL-STAR NUWAY & GENERIC E ASP-BP

K-Number: K833451 · 1983-11-14

ApplicantOmni Hearing Systems
Decision Date1983-11-14
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TEL-STAR NUWAY & GENERIC E ASP-BP 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 1983-11-14 under 510(k) number K833451. 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 TEL-STAR NUWAY & GENERIC E ASP-BP?

TEL-STAR NUWAY & GENERIC E ASP-BP is a medical device that received FDA 510(k) clearance on 1983-11-14. The listed applicant is Omni Hearing Systems. The 510(k) number is K833451.

When did TEL-STAR NUWAY & GENERIC E ASP-BP receive FDA 510(k) clearance?

TEL-STAR NUWAY & GENERIC E ASP-BP received FDA 510(k) clearance on 1983-11-14, under 510(k) number K833451.

Who is the listed applicant for TEL-STAR NUWAY & GENERIC E ASP-BP?

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 TEL-STAR NUWAY & GENERIC E ASP-BP?

The FDA product code for TEL-STAR NUWAY & GENERIC E ASP-BP 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-BBK830459BEHIND THE EAR HEARING AID OMNI #OSK823178TEL-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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