Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S— 510(k) K082173
Substantially EquivalentCardiac Science Corporation
FDA 510(k) clearance K082173 for Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S, Substantially Equivalent on 2008-08-26. Applicant: Cardiac Science Corporation.
Clearance details
- Applicant
- Cardiac Science Corporation
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bothell, WA, US
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
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.