Non-Sterile Ultrasound Transmission Gels— 510(k) K241789

Name: FDA 510(k) clearance K241789
Creator: U.S. Food and Drug Administration
Published: 2024-07-24

Substantially Equivalent

Hony Medical Co., Ltd.

FDA 510(k) clearance K241789 for Non-Sterile Ultrasound Transmission Gels, Substantially Equivalent on 2024-07-24. Applicant: Hony Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hony Medical Co., Ltd.
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2024-06-21
Decision date: 2024-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taishan, 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.