Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
FDA 510(k) clearance K250548 · decided 2025-06-26
Clearance details
- K-number
- K250548
- Device name
- Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
- Applicant
- Joytech Healthcare Co. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-02-25
- Decision date
- 2025-06-26
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.