UNI-PATCH ULTRASOUND COUPLING GEL— 510(k) K021132

Name: FDA 510(k) clearance K021132
Creator: U.S. Food and Drug Administration
Published: 2002-05-15

Substantially Equivalent

The Ludlow Company LP

FDA 510(k) clearance K021132 for UNI-PATCH ULTRASOUND COUPLING GEL, Substantially Equivalent on 2002-05-15. Applicant: The Ludlow Company LP. Device class: 2.

Clearance details

Applicant: The Ludlow Company LP
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2002-04-09
Decision date: 2002-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicopee, MA, 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.