PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-— 510(k) K982432

Name: FDA 510(k) clearance K982432
Creator: U.S. Food and Drug Administration
Published: 1999-01-25

Substantially Equivalent

Tinnitus Treatment Centers, Inc.

FDA 510(k) clearance K982432 for PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-, Substantially Equivalent on 1999-01-25. Applicant: Tinnitus Treatment Centers, Inc.. Device class: 2.

Clearance details

Applicant: Tinnitus Treatment Centers, Inc.
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 1998-07-13
Decision date: 1999-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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