INFRARED SCIENCES BREASTSCAN IR SYSTEM— 510(k) K032350

Name: FDA 510(k) clearance K032350
Creator: U.S. Food and Drug Administration
Published: 2004-02-20

Substantially Equivalent

Infrared Sciences Corp.

FDA 510(k) clearance K032350 for INFRARED SCIENCES BREASTSCAN IR SYSTEM, Substantially Equivalent on 2004-02-20. Applicant: Infrared Sciences Corp.. Device class: 1.

Clearance details

Applicant: Infrared Sciences Corp.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2003-07-30
Decision date: 2004-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, 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.