AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301— 510(k) K101641

Name: FDA 510(k) clearance K101641
Creator: U.S. Food and Drug Administration
Published: 2011-06-16

Substantially Equivalent

Ag Digital Technology Corp.

FDA 510(k) clearance K101641 for AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301, Substantially Equivalent on 2011-06-16. Applicant: Ag Digital Technology Corp.. Device class: 1.

Clearance details

Applicant: Ag Digital Technology Corp.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2010-06-10
Decision date: 2011-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, 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.