Sterile and Non-Sterile Ultrasound Gels— 510(k) K232957

Name: FDA 510(k) clearance K232957
Creator: U.S. Food and Drug Administration
Published: 2023-12-15

Substantially Equivalent

Jianerkang Medical Co., Ltd.

FDA 510(k) clearance K232957 for Sterile and Non-Sterile Ultrasound Gels, Substantially Equivalent on 2023-12-15. Applicant: Jianerkang Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Jianerkang Medical Co., Ltd.
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2023-09-21
Decision date: 2023-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Download summary PDF View on FDA.gov ↗

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