Sterile and Non-Sterile Ultrasonic Coupling Agent— 510(k) K242167

Name: FDA 510(k) clearance K242167
Creator: U.S. Food and Drug Administration
Published: 2024-09-19

Substantially Equivalent

Anhui Deepblue Medical Technology Co., Ltd.

FDA 510(k) clearance K242167 for Sterile and Non-Sterile Ultrasonic Coupling Agent, Substantially Equivalent on 2024-09-19. Applicant: Anhui Deepblue Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Anhui Deepblue Medical Technology Co., Ltd.
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2024-07-24
Decision date: 2024-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hefei, 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.