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FDA 510(k)

SOUNDRIGHT, SHP

K-Number: K935420 · 1993-12-15

ApplicantSoundright Hearing Products
Decision Date1993-12-15
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SOUNDRIGHT, SHP is the device name listed in this FDA 510(k) record. The listed applicant is Soundright Hearing Products. It received FDA 510(k) clearance on 1993-12-15 under 510(k) number K935420. 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 SOUNDRIGHT, SHP?

SOUNDRIGHT, SHP is a medical device that received FDA 510(k) clearance on 1993-12-15. The listed applicant is Soundright Hearing Products. The 510(k) number is K935420.

When did SOUNDRIGHT, SHP receive FDA 510(k) clearance?

SOUNDRIGHT, SHP received FDA 510(k) clearance on 1993-12-15, under 510(k) number K935420.

Who is the listed applicant for SOUNDRIGHT, SHP?

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

What is the FDA product code for SOUNDRIGHT, SHP?

The FDA product code for SOUNDRIGHT, SHP is ESD.

Related Clinical Trials

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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