InTouch Thermal Camera— 510(k) K181716

Name: FDA 510(k) clearance K181716
Creator: U.S. Food and Drug Administration
Published: 2019-03-25

Substantially Equivalent

Intouch Technologies, Inc., D.B.A. Intouch Health

FDA 510(k) clearance K181716 for InTouch Thermal Camera, Substantially Equivalent on 2019-03-25. Applicant: Intouch Technologies, Inc., D.B.A. Intouch Health. Device class: 1.

Clearance details

Applicant: Intouch Technologies, Inc., D.B.A. Intouch Health
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2018-06-28
Decision date: 2019-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, 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.