SERIES 4000 STRESS & EXERCISE SYSTEM— 510(k) K801903
Substantially EquivalentInstruments For Cardiac Research
FDA 510(k) clearance K801903 for SERIES 4000 STRESS & EXERCISE SYSTEM, Substantially Equivalent on 1981-03-11. Applicant: Instruments For Cardiac Research.
Clearance details
- Applicant
- Instruments For Cardiac Research
- Product code
- Code DSI
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Adverse events under product code DSI
product code DSI- Death
- 170
- Injury
- 729
- Malfunction
- 10,680
- Total
- 11,579
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.