TM-400— 510(k) K081247

Substantially Equivalent

Ito Co., Ltd.

FDA 510(k) clearance K081247 for TM-400, Substantially Equivalent on 2008-08-25. Applicant: Ito Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ito Co., Ltd.
Product code: Code ITH
Device class: Class 2
Regulation: 21 CFR 890.5900
Advisory panel: Physical Medicine
Date received: 2008-05-01
Decision date: 2008-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

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