FDA.report

510(k) K242167

Device
Sterile and Non-Sterile Ultrasonic Coupling Agent
Applicant
Anhui Deepblue Medical Technology Co., Ltd.
510(k) number
K242167
Product code
MUI
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-19
Date received
2024-07-24
Regulation
892.1570
Classification name
Media, Coupling, Ultrasound
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Fengling Chen
Address
# 777 Jimingshan Rd., High-Tech Development Zone Hefei CN 230088 230088

FDA Registration Numbers

Source Documents

510(k) summary PDF

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