CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM— 510(k) K911943

Name: FDA 510(k) clearance K911943
Creator: U.S. Food and Drug Administration
Published: 1991-07-19

Substantially Equivalent

Burke, Inc.

FDA 510(k) clearance K911943 for CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM, Substantially Equivalent on 1991-07-19. Applicant: Burke, Inc.. Device class: 2.

Clearance details

Applicant: Burke, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1991-05-01
Decision date: 1991-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

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