ULTRA (THERAPEUTIC ULTRASOUND DEVICE)— 510(k) K895690

Name: FDA 510(k) clearance K895690
Creator: U.S. Food and Drug Administration
Published: 1990-02-20

Substantially Equivalent

Excel Tech. , Ltd.

FDA 510(k) clearance K895690 for ULTRA (THERAPEUTIC ULTRASOUND DEVICE), Substantially Equivalent on 1990-02-20. Applicant: Excel Tech. , Ltd.. Device class: 2.

Clearance details

Applicant: Excel Tech. , Ltd.
Product code: Code IMG
Device class: Class 2
Regulation: 21 CFR 890.5860
Advisory panel: Physical Medicine
Date received: 1989-09-22
Decision date: 1990-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville,Ontario, CA

Download summary PDF View on FDA.gov ↗

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