THERMATREK IRIS-3 INFRARED IMAGING SYSTEM— 510(k) K982112

Name: FDA 510(k) clearance K982112
Creator: U.S. Food and Drug Administration
Published: 1998-08-20

Substantially Equivalent

Thermatrek, Inc.

FDA 510(k) clearance K982112 for THERMATREK IRIS-3 INFRARED IMAGING SYSTEM, Substantially Equivalent on 1998-08-20. Applicant: Thermatrek, Inc.. Device class: 1.

Clearance details

Applicant: Thermatrek, Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 1998-06-16
Decision date: 1998-08-20
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.