Search Results
Found 1 results
510(k) Data Aggregation
K Number
K974501Device Name
DIGITAL TINNITUS MASKING SYSTEM
Manufacturer
PETROFF AUDIO TECHNOLOGIES
Date Cleared
1998-01-20
(53 days)
Product Code
KLW
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
PETROFF AUDIO TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Each of the four CDs included in the DTM-4 CD set (CD#1, CD#2, CD#3 and CD#4), and each of the four tapes included the DTM-4 TAPE set (TAPE#1, TAPE#2, TAPE#3 and TAPE#4), provide digital tinnitus masking when operated on any commercially available CD or tape player respectively, using any commercially available headphones or speakers. CD#1 and TAPE#1 provide digital tinnitus masking sounds only and are indicated for temporary relief of tinnitus symptoms. CD#2, CD#3, CD#4, TAPE#2, TAPE#3 and TAPE#4 provide digital tinnitus masking sounds plus relaxation messages, alpha-rhythms (a gentle musical sound generated on electronic musical instruments), music and/or nature sounds, and are indicated for temporary relief of tinnitus symptoms and the promotion of relaxation during the tinnitus masking process.
Device Description
Not Found
Ask a Question
Page 1 of 1