A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200— 510(k) K101002
Substantially EquivalentHealthstats International Pte. , Ltd.
FDA 510(k) clearance K101002 for A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200, Substantially Equivalent on 2010-06-08. Applicant: Healthstats International Pte. , Ltd..
Clearance details
- Applicant
- Healthstats International Pte. , Ltd.
- Product code
- Code DXN
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Egale, WI, US
Adverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
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.