AlfaSight 9000 Thermographic System— 510(k) K150457

Name: FDA 510(k) clearance K150457
Creator: U.S. Food and Drug Administration
Published: 2015-04-10

Substantially Equivalent

Alfa Thermodiagnostics, Inc.

FDA 510(k) clearance K150457 for AlfaSight 9000 Thermographic System, Substantially Equivalent on 2015-04-10. Applicant: Alfa Thermodiagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Alfa Thermodiagnostics, Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2015-02-20
Decision date: 2015-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aptos, CA, US

Download summary PDF View on FDA.gov ↗

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