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510(k) K233076

Device
Laser Speckle Imaging System (RFLSI CZW)
Applicant
Rwd Life Science Co., Ltd.
510(k) number
K233076
Product code
DPT
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-28
Date received
2023-09-26
Regulation
870.2120
Classification name
Probe, Blood-Flow, Extravascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Xuhong Wang
Address
19f, Bldg. 9a, Vanke Cloud City Iii, Liuxin 4 St., Nanshan District Shenzhen CN 518000 518000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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