TONE-A-MATIC— 510(k) K130052

Substantially Equivalent

Tone-A-Matic International, Inc.

FDA 510(k) clearance K130052 for TONE-A-MATIC, Substantially Equivalent on 2013-12-20. Applicant: Tone-A-Matic International, Inc.. Device class: 2.

Clearance details

Applicant: Tone-A-Matic International, Inc.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2013-01-09
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.