BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM— 510(k) K850534

Name: FDA 510(k) clearance K850534
Creator: U.S. Food and Drug Administration
Published: 1985-02-27

Substantially Equivalent

Bales Scientific, Inc.

FDA 510(k) clearance K850534 for BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM, Substantially Equivalent on 1985-02-27. Applicant: Bales Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Bales Scientific, Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 1985-02-11
Decision date: 1985-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, CA, US

Download summary PDF View on FDA.gov ↗

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