Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
FDA 510(k) clearance K222887 · decided 2023-04-10
Clearance details
- K-number
- K222887
- Device name
- Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
- Applicant
- Famidoc Technology Company Limited
- Decision
- Substantially Equivalent
- Date received
- 2022-09-23
- Decision date
- 2023-04-10
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Dongguan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.