REGUTHERM 952 THERMOGRAPHIC SYSTEM— 510(k) K003130

Name: FDA 510(k) clearance K003130
Creator: U.S. Food and Drug Administration
Published: 2001-02-16

Substantially Equivalent

Sie-Med, Inc.

FDA 510(k) clearance K003130 for REGUTHERM 952 THERMOGRAPHIC SYSTEM, Substantially Equivalent on 2001-02-16. Applicant: Sie-Med, Inc.. Device class: 1.

Clearance details

Applicant: Sie-Med, Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2000-10-06
Decision date: 2001-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarksville, MD, US

Download summary PDF View on FDA.gov ↗

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