INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE— 510(k) K093632
Substantially EquivalentDrager Medical AG & Co. Kgaa
FDA 510(k) clearance K093632 for INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE, Substantially Equivalent on 2010-04-05. Applicant: Drager Medical AG & Co. Kgaa.
Clearance details
- Applicant
- Drager Medical AG & Co. Kgaa
- Product code
- Code CBK
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Telford, PA, US
Adverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
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.