ThermPix Thermovisual Camera— 510(k) K232462

Substantially Equivalent

Usa Therm, Inc.

FDA 510(k) clearance K232462 for ThermPix Thermovisual Camera, Substantially Equivalent on 2023-09-14. 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: 2023-08-15
Decision date: 2023-09-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Fort Lauderdale, 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.