CARE PAL, MODEL CPW-10X— 510(k) K091430
Substantially EquivalentDigio2 International Co., Ltd.
FDA 510(k) clearance K091430 for CARE PAL, MODEL CPW-10X, Substantially Equivalent on 2009-08-21. Applicant: Digio2 International Co., Ltd..
Clearance details
- Applicant
- Digio2 International Co., Ltd.
- Product code
- Code DRG
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Flagstaff, AZ, US
Adverse events under product code DRG
product code DRG- Death
- 5
- Total
- 5
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.