510(k) clearances

Laser Speckle Imaging System (RFLSI CZW)

Rwd Life Science Co., Ltd. · Cardiovascular

K233076Substantially EquivalentTraditionalDPT
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
Cardiovascular
Address 1
19f, Bldg. 9a, Vanke Cloud City Iii, Liuxin 4 St.,
Address 2
Nanshan District
Statement or summary
Summary
Product code
DPT
Zip code
518000
Applicant
Rwd Life Science Co., Ltd.
Decision date
2024-05-28
Decision code
SESE
Country code
CN
Device name
Laser Speckle Imaging System (RFLSI CZW)
Advisory committee
CV
Contact
Xuhong Wang
K number
K233076
Date received
2023-09-26
Review advisory committee
SU
Postal code
518000
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Probe, Blood-Flow, Extravascular
Medical specialty description
Cardiovascular
Regulation number
870.2120
Device class
2
Registration number
2025816, 8030885, 3021013124, 3008483389, 3003647374, 1422634, 9616567, 9680933, 3013596024, 3013500228, 1526863, 2184009, 9613067, 3044156918, 1928237, 8043564, 3005941719, 9617601, 2011171
FEI number
2025816, 3021013124, 3002963732, 3008483389, 1000637007, 3003647374, 3003244961, 1000279065, 3013596024, 3002807111, 3013500228, 1000116158, 1526863, 1000514656, 3044156918, 1928237, 3002534070, 3010790133, 2011171
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.