Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)
FDA 510(k) clearance K231367 · decided 2023-09-18
Clearance details
- K-number
- K231367
- Device name
- Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)
- Applicant
- Shenzhen Finicare Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-05-11
- Decision date
- 2023-09-18
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.