THERMATREK IRIS-IV INFRARED IMAGING SYSTEM— 510(k) K030165

Name: FDA 510(k) clearance K030165
Creator: U.S. Food and Drug Administration
Published: 2003-04-16

Substantially Equivalent

Thermatrek

FDA 510(k) clearance K030165 for THERMATREK IRIS-IV INFRARED IMAGING SYSTEM, Substantially Equivalent on 2003-04-16. Applicant: Thermatrek. Device class: 1.

Clearance details

Applicant: Thermatrek
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2003-01-16
Decision date: 2003-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodbury, CT, 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.