BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System— 510(k) K220421
Substantially EquivalentApex BioTechnology Corp.
FDA 510(k) clearance K220421 for BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System, Substantially Equivalent on 2022-11-04. Applicant: Apex BioTechnology Corp.. Device class: 2.
Clearance details
- Applicant
- Apex BioTechnology Corp.
- 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
- Hsinchu, CN
Recent devices under product code NBW
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- K260545 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more
More clearances from Apex BioTechnology Corp.
view allAdverse 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.