Thermidas IR System (ThIR-A615)— 510(k) K200999

Name: FDA 510(k) clearance K200999
Creator: U.S. Food and Drug Administration
Published: 2021-01-06

Substantially Equivalent

Thermidas Americas, Inc.

FDA 510(k) clearance K200999 for Thermidas IR System (ThIR-A615), Substantially Equivalent on 2021-01-06. Applicant: Thermidas Americas, Inc.. Device class: 1.

Clearance details

Applicant: Thermidas Americas, Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2020-04-16
Decision date: 2021-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Pasadena, FL, US

Download summary PDF View on FDA.gov ↗

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