ThermPix Thermovisual Camera— 510(k) K213650

Substantially Equivalent

Usa Therm, Inc.

FDA 510(k) clearance K213650 for ThermPix Thermovisual Camera, Substantially Equivalent on 2022-04-12. Applicant: Usa Therm, Inc.. Device class: 1.

Clearance details

Applicant: Usa Therm, Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2021-11-19
Decision date: 2022-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aventura, FL, 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.