T-570 TINNITUS MASKER— 510(k) K800701
Substantially EquivalentAudiotrone
FDA 510(k) clearance K800701 for T-570 TINNITUS MASKER, Substantially Equivalent on 1980-04-10. Applicant: Audiotrone. Device class: 2.
Clearance details
- Applicant
- Audiotrone
- Product code
- Code KLW
- Device class
- Class 2
- Regulation
- 21 CFR 874.3400
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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