PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR.— 510(k) K051862
Substantially EquivalentYa Horng Electronic Co., Ltd.
FDA 510(k) clearance K051862 for PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR., Substantially Equivalent on 2005-08-23. Applicant: Ya Horng Electronic Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Ya Horng Electronic Co., 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
- Traditional
- Location
- Hsin Chu City, TW
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More clearances from Ya Horng Electronic Co., Ltd.
view all- K221486 — INDEX BPM
- K121025 — YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION
- K090058 — YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB
- K081590 — YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J
- K072860 — YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500
Adverse 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.