KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR— 510(k) K102609
Substantially EquivalentAndon Medical Co., Ltd.
FDA 510(k) clearance K102609 for KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, Substantially Equivalent on 2010-12-09. Applicant: Andon Medical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Andon Medical 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
- Abbreviated
- Location
- Tianjin, CN
Recent devices under product code DXN
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- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
More clearances from Andon Medical Co., Ltd.
view all- K123935 — IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
- K120813 — BLOOD GLUCOSE MONITORING SYSTEM
- K110017 — AG-608N BLOOD GLUCOSE MONITORING SYSTEM
- K112738 — ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
- K102678 — ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
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.