FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR— 510(k) K121470
Substantially EquivalentAndon Health Co, Ltd.
FDA 510(k) clearance K121470 for FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR, Substantially Equivalent on 2012-06-14. Applicant: Andon Health Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Andon Health 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
- Special
- Location
- Tianjin, CN
Recent devices under product code DXN
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More clearances from Andon Health Co, Ltd.
view all- K251113 — iHealth Compare Wireless Blood Pressure Monitor(BP-300C) +9 more
- K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
- K234041 — Fully Automatic Electronic Blood Pressure Monitor (7 models)
- K222869 — Arm Blood Pressure Monitor
- K222867 — AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
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.