CRT2000 THERMOGRAPHIC SYSTEM— 510(k) K971956

Name: FDA 510(k) clearance K971956
Creator: U.S. Food and Drug Administration
Published: 1997-08-22

Substantially Equivalent

Werner Eidam Medizin-Technologie GmbH

FDA 510(k) clearance K971956 for CRT2000 THERMOGRAPHIC SYSTEM, Substantially Equivalent on 1997-08-22. Applicant: Werner Eidam Medizin-Technologie GmbH. Device class: 1.

Clearance details

Applicant: Werner Eidam Medizin-Technologie GmbH
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 1997-05-27
Decision date: 1997-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.