PowerDot PD-01MT— 510(k) K181759

Name: FDA 510(k) clearance K181759
Creator: U.S. Food and Drug Administration
Published: 2018-11-09

Substantially Equivalent

Smartmissimo Technologies Pte, Ltd.

FDA 510(k) clearance K181759 for PowerDot PD-01MT, Substantially Equivalent on 2018-11-09. Applicant: Smartmissimo Technologies Pte, Ltd.. Device class: 2.

Clearance details

Applicant: Smartmissimo Technologies Pte, Ltd.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2018-07-02
Decision date: 2018-11-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

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