FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM— 510(k) K101926
Substantially EquivalentTaidoc Technology Corporation
FDA 510(k) clearance K101926 for FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, Substantially Equivalent on 2011-12-20. Applicant: Taidoc Technology Corporation. Device class: 2.
Clearance details
- Applicant
- Taidoc Technology Corporation
- 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
- Taipei County, 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.