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#
- 3003990090
- 3006950086
- 9614434
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