A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512
FDA 510(k) clearance K042967 · decided 2004-12-03
Clearance details
- K-number
- K042967
- Device name
- A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512
- Applicant
- A&D Engineering, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-10-28
- Decision date
- 2004-12-03
- Days to decision
- 36 days
- Clearance type
- Special
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Milpitas, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.