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FDA 510(k)

NU-EAR SD-10 IN THE CANAL HEARING AID

K-Number: K935326 · 1994-01-21

ApplicantNu-Ear Electronics
Decision Date1994-01-21
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NU-EAR SD-10 IN THE CANAL HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Nu-Ear Electronics. It received FDA 510(k) clearance on 1994-01-21 under 510(k) number K935326. 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 NU-EAR SD-10 IN THE CANAL HEARING AID?

NU-EAR SD-10 IN THE CANAL HEARING AID is a medical device that received FDA 510(k) clearance on 1994-01-21. The listed applicant is Nu-Ear Electronics. The 510(k) number is K935326.

When did NU-EAR SD-10 IN THE CANAL HEARING AID receive FDA 510(k) clearance?

NU-EAR SD-10 IN THE CANAL HEARING AID received FDA 510(k) clearance on 1994-01-21, under 510(k) number K935326.

Who is the listed applicant for NU-EAR SD-10 IN THE CANAL HEARING AID?

The FDA 510(k) record lists Nu-Ear Electronics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NU-EAR SD-10 IN THE CANAL HEARING AID?

The FDA product code for NU-EAR SD-10 IN THE CANAL HEARING AID is ESD.

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Other records listing Nu-Ear Electronics 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.

K935329NU.EAR AE-2 IN THE CANAL (ITC) HEARING AIDK935335NU.EAR SS-10 IN THE CANAL (ITC) HEARING AIDK935328NU.EAR SS-2 IN THE CANAL (ITC) HEARING AIDK935331NU.EAR SD-3 IN THE CANAL (ITC) HEARING AIDK935334NU.EAR SD-1 IN THE EAR (ITE) HEARING AIDK935332NU.EAR AE-1 IN THE EAR (ITE) HEARING AID

View all 10 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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