FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750
FDA 510(k) clearance K071523 · decided 2007-06-26
Clearance details
- K-number
- K071523
- Device name
- FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750
- Applicant
- Genexel-Sein, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-04
- Decision date
- 2007-06-26
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Roswell, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.