IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION— 510(k) K130535
Substantially EquivalentAgamatrix, Inc.
FDA 510(k) clearance K130535 for IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, Substantially Equivalent on 2013-04-17. Applicant: Agamatrix, Inc.. Device class: 2.
Clearance details
- Applicant
- Agamatrix, Inc.
- Product code
- Product code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salem, NH, US
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More clearances from Agamatrix, Inc.
view all- K161834 — One Drop Blood Glucose Monitoring System
- K152365 — AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
- K132821 — AGAMATRIX HEALTH MANAGER
- K103544 — IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D
- K083265 — JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
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.