BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE
FDA 510(k) clearance K091553 · decided 2009-09-21
Clearance details
- K-number
- K091553
- Device name
- BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE
- Applicant
- Ningbo Diaier Electronic Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-05-27
- Decision date
- 2009-09-21
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Yuyao City, Zhejiang, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.