BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951— 510(k) K101307
Substantially EquivalentAndon Medical Co., Ltd.
FDA 510(k) clearance K101307 for BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951, Substantially Equivalent on 2011-08-09. Applicant: Andon Medical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Andon Medical Co., Ltd.
- Product code
- Code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tianjin, CN
Recent devices under product code NBW
view all- K260545 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more
- K262116 — TRUE METRIX Self Monitoring Blood Glucose System
- K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more
- K243060 — TeleRPM Gen2 Blood Glucose Monitoring System
- K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel
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 NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
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.