S3 CARDIOPLEGIA CONTROL— 510(k) K962320
Substantially EquivalentStoeckert Instrumente
FDA 510(k) clearance K962320 for S3 CARDIOPLEGIA CONTROL, Substantially Equivalent on 1997-01-10. Applicant: Stoeckert Instrumente.
Clearance details
- Applicant
- Stoeckert Instrumente
- Product code
- Code DTR
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
Adverse events under product code DTR
product code DTR- Other
- 1
- Total
- 1
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.