US-100 PORTABLE ULTRASOUND THERAPY UNIT— 510(k) K032793

Name: FDA 510(k) clearance K032793
Creator: U.S. Food and Drug Administration
Published: 2003-10-09

Substantially Equivalent

Ito Co., Ltd.

FDA 510(k) clearance K032793 for US-100 PORTABLE ULTRASOUND THERAPY UNIT, Substantially Equivalent on 2003-10-09. Applicant: Ito Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ito Co., Ltd.
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2003-09-09
Decision date: 2003-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brookeville, MD, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.