TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM— 510(k) K032585

Name: FDA 510(k) clearance K032585
Creator: U.S. Food and Drug Administration
Published: 2004-01-09

Substantially Equivalent

Ron-Tech Medical , Ltd.

FDA 510(k) clearance K032585 for TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM, Substantially Equivalent on 2004-01-09. Applicant: Ron-Tech Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Ron-Tech Medical , Ltd.
Product code: Code HDC
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2003-08-21
Decision date: 2004-01-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Petach-Tikva, IL

Download summary PDF View on FDA.gov ↗

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