TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB— 510(k) K020783

Name: FDA 510(k) clearance K020783
Creator: U.S. Food and Drug Administration
Published: 2002-06-07

Substantially Equivalent

Telesis Technologies, Inc.

FDA 510(k) clearance K020783 for TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB, Substantially Equivalent on 2002-06-07. Applicant: Telesis Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Telesis Technologies, Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2002-03-11
Decision date: 2002-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: His-Chih City, Taipei Hsien, TW

Download summary PDF View on FDA.gov ↗

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