Sonishield 100 Antimicrobial Ultrasound Gel— 510(k) K151070

Name: FDA 510(k) clearance K151070
Creator: U.S. Food and Drug Administration
Published: 2016-01-13

Substantially Equivalent

Quotient Medical

FDA 510(k) clearance K151070 for Sonishield 100 Antimicrobial Ultrasound Gel, Substantially Equivalent on 2016-01-13. Applicant: Quotient Medical. Device class: 2.

Clearance details

Applicant: Quotient Medical
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2015-04-21
Decision date: 2016-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, CA

Download summary PDF View on FDA.gov ↗

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