CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0— 510(k) K070941
Substantially EquivalentTaidoc Technology Corporation
FDA 510(k) clearance K070941 for CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0, Substantially Equivalent on 2007-06-21. Applicant: Taidoc Technology Corporation. Device class: 2.
Clearance details
- Applicant
- Taidoc Technology Corporation
- 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
- Traditional
- Location
- San Chung, Taipei, 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.