BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System— 510(k) K160365
Substantially EquivalentInfopia Co, Ltd.
FDA 510(k) clearance K160365 for BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System, Substantially Equivalent on 2016-09-28. Applicant: Infopia Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Infopia 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
- Special
- Location
- Anyang, KR
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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.