Ultra/Phonic Free Conductivity Gel— 510(k) K163027

Name: FDA 510(k) clearance K163027
Creator: U.S. Food and Drug Administration
Published: 2018-01-09

Substantially Equivalent

Pharmaceutical Innovations, Inc.

FDA 510(k) clearance K163027 for Ultra/Phonic Free Conductivity Gel, Substantially Equivalent on 2018-01-09. Applicant: Pharmaceutical Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Pharmaceutical Innovations, Inc.
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2016-10-31
Decision date: 2018-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, NJ, 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.