Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)
FDA 510(k) clearance K253142 · decided 2026-01-09
Clearance details
- K-number
- K253142
- Device name
- Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)
- Applicant
- Ningbo Ranor Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-25
- Decision date
- 2026-01-09
- Days to decision
- 106 days
- Clearance type
- Special
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ningbo, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.