EcoVue Sterile and Non-Sterile Ultrasound Gels— 510(k) K181363

Name: FDA 510(k) clearance K181363
Creator: U.S. Food and Drug Administration
Published: 2018-06-13

Substantially Equivalent

H R Pharmaceuticals, Inc.

FDA 510(k) clearance K181363 for EcoVue Sterile and Non-Sterile Ultrasound Gels, Substantially Equivalent on 2018-06-13. Applicant: H R Pharmaceuticals, Inc.. Device class: 2.

Clearance details

Applicant: H R Pharmaceuticals, Inc.
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2018-05-23
Decision date: 2018-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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