ENGSTROM HMEF 1000— 510(k) K964204
Substantially EquivalentDatex Engstrom AB
FDA 510(k) clearance K964204 for ENGSTROM HMEF 1000, Substantially Equivalent on 1996-11-13. Applicant: Datex Engstrom AB.
Clearance details
- Applicant
- Datex Engstrom AB
- Product code
- Code CAH
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mccordsville, IN, US
Adverse events under product code CAH
product code CAH- 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.