A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor— 510(k) K170196
Substantially EquivalentA&D Company, Ltd.
FDA 510(k) clearance K170196 for A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor, Substantially Equivalent on 2017-05-17. Applicant: A&D Company, Ltd.. Device class: 2.
Clearance details
- Applicant
- A&D Company, Ltd.
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
Recent devices under product code DXN
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- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
More clearances from A&D Company, Ltd.
view allAdverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.