ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE— 510(k) K970131

Name: FDA 510(k) clearance K970131
Creator: U.S. Food and Drug Administration
Published: 1997-06-16

Substantially Equivalent

C.L. Mcintosh & Assoc., Inc.

FDA 510(k) clearance K970131 for ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE, Substantially Equivalent on 1997-06-16. Applicant: C.L. Mcintosh & Assoc., Inc.. Device class: 2.

Clearance details

Applicant: C.L. Mcintosh & Assoc., Inc.
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 1997-01-14
Decision date: 1997-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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