SW-THERM— 510(k) K131899

Name: FDA 510(k) clearance K131899
Creator: U.S. Food and Drug Administration
Published: 2014-03-14

Substantially Equivalent

Shenzhen Dongdixin Technology Co., Ltd.

FDA 510(k) clearance K131899 for SW-THERM, Substantially Equivalent on 2014-03-14. Applicant: Shenzhen Dongdixin Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Dongdixin Technology Co., Ltd.
Product code: Code IMJ
Device class: Class 2
Regulation: 21 CFR 890.5290
Advisory panel: Physical Medicine
Date received: 2013-06-25
Decision date: 2014-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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