Fully Automatic Electronic Blood Pressure Monitor
FDA 510(k) clearance K151460 · decided 2015-09-08
Clearance details
- K-number
- K151460
- Device name
- Fully Automatic Electronic Blood Pressure Monitor
- Applicant
- Andon Health Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-06-01
- Decision date
- 2015-09-08
- Days to decision
- 99 days
- Clearance type
- Special
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tianjin, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.