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510(k) Data Aggregation
K Number
K013827Device Name
TST - SUPPRESSOR MODEL #1000
Manufacturer
Date Cleared
2002-05-21
(183 days)
Product Code
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
NEUROSIM LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TST Suppressor 1000 device is selected sound tracks delivered to the ear by a Standard digital audio player and using an air-conduction earpiece or headphone type transadeers: The 151 Saperience relief of their Tinnitus symptoms when using the Hintus Sunerers who expending fair to excellent hearing in the frequency range 100 device and vince out. Pan there is no more than 35 dB loss in the affected ear in that frequency range and where their Tinnitus is unilateral or bilateral.
The TST Suppressor 1000 is for home use.
Each TST Suppressor 1000 device may be used to suppress the symptoms of tinnitus Eden 191 Suppresser Loigital audio player, using commercially available earphones or headphones.
Device Description
The TST Suppressor 1000 device is selected sound tracks delivered to the ear by a Standard digital audio player and using an air-conduction earpiece or headphone type transadeers.
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