510(k) K222162

Device
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Applicant
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510(k) number
K222162
Product code
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Decision
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Decision date
2022-11-09
Date received
2022-07-21
Regulation
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Classification name
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Medical specialty
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Review panel
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Device class
2
Clearance type
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Statement or summary
Summary
Third party reviewed
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Applicant Contact#

Contact
Shuwen Fan
Address
3 & 4 Floor, #2 Bldg., 366 Huiqing Rd. East Zhangjiang High-Tech Park Shanghai CN 201201 201201

FDA Registration Numbers#

Source Documents#

510(k) summary PDF