BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System— 510(k) K161299
Substantially EquivalentApex BioTechnology Corp.
FDA 510(k) clearance K161299 for BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System, Substantially Equivalent on 2016-12-23. Applicant: Apex BioTechnology Corp.. Device class: 2.
Clearance details
- Applicant
- Apex BioTechnology Corp.
- 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
- Hsinchu, TW
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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.