MARK I THERMAL IMAGER— 510(k) K023925

Substantially Equivalent

Ix-Dr, Inc.

FDA 510(k) clearance K023925 for MARK I THERMAL IMAGER, Substantially Equivalent on 2003-02-11. Applicant: Ix-Dr, Inc.. Device class: 1.

Clearance details

Applicant: Ix-Dr, Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2002-11-25
Decision date: 2003-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Howell, MI, 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.