UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES
FDA 510(k) clearance K092514 · decided 2009-12-04
Clearance details
- K-number
- K092514
- Device name
- UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES
- Applicant
- Hangzhou Hua'An Medical & Health Instruments Co.,
- Decision
- Substantially Equivalent
- Date received
- 2009-08-17
- Decision date
- 2009-12-04
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Wuchang, Hangzhou, Zhejiang, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.