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FDA 510(k)

SONOTONE BEHIND THE EAR MODEL ST 54-0

K-Number: K914897 · 1992-01-10

ApplicantSonotone Intl., Inc.
Decision Date1992-01-10
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SONOTONE BEHIND THE EAR MODEL ST 54-0 is the device name listed in this FDA 510(k) record. The listed applicant is Sonotone Intl., Inc.. It received FDA 510(k) clearance on 1992-01-10 under 510(k) number K914897. 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 SONOTONE BEHIND THE EAR MODEL ST 54-0?

SONOTONE BEHIND THE EAR MODEL ST 54-0 is a medical device that received FDA 510(k) clearance on 1992-01-10. The listed applicant is Sonotone Intl., Inc.. The 510(k) number is K914897.

When did SONOTONE BEHIND THE EAR MODEL ST 54-0 receive FDA 510(k) clearance?

SONOTONE BEHIND THE EAR MODEL ST 54-0 received FDA 510(k) clearance on 1992-01-10, under 510(k) number K914897.

Who is the listed applicant for SONOTONE BEHIND THE EAR MODEL ST 54-0?

The FDA 510(k) record lists Sonotone Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOTONE BEHIND THE EAR MODEL ST 54-0?

The FDA product code for SONOTONE BEHIND THE EAR MODEL ST 54-0 is ESD.

Related Clinical Trials

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.

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Other records listing Sonotone Intl., Inc. 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.

K915518SONOTONE BEHIND THE EAR MODEL ST 49K915517SONOTONE BODY AID MODEL ST 1000 BODY WORNK915519SONOTONE BEHIND THE EAR MODEL ST 53A

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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