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U.S. Department of Health and Human Services

Product Classification

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Device masker, tinnitus
Regulation Description Tinnitus masker.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeKLW
Premarket Review ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type 510(k)
Regulation Number 874.3400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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