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FDA 510(k)

SONOTONE BEHIND THE EAR MODEL ST 49

K-Number: K915518 · 1992-01-09

ApplicantSonotone Intl., Inc.
Decision Date1992-01-09
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SONOTONE BEHIND THE EAR MODEL ST 49 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 1992-01-09 under 510(k) number K915518. 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 49?

SONOTONE BEHIND THE EAR MODEL ST 49 is a medical device that received FDA 510(k) clearance on 1992-01-09. The listed applicant is Sonotone Intl., Inc.. The 510(k) number is K915518.

When did SONOTONE BEHIND THE EAR MODEL ST 49 receive FDA 510(k) clearance?

SONOTONE BEHIND THE EAR MODEL ST 49 received FDA 510(k) clearance on 1992-01-09, under 510(k) number K915518.

Who is the listed applicant for SONOTONE BEHIND THE EAR MODEL ST 49?

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 49?

The FDA product code for SONOTONE BEHIND THE EAR MODEL ST 49 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K914897SONOTONE BEHIND THE EAR MODEL ST 54-0K915517SONOTONE 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

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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