ROTEM DELTA THROMBOELASTOMETRY SYSTEM— 510(k) K083842
Substantially EquivalentPentapharm GmbH
FDA 510(k) clearance K083842 for ROTEM DELTA THROMBOELASTOMETRY SYSTEM, Substantially Equivalent on 2010-03-23. Applicant: Pentapharm GmbH.
Clearance details
- Applicant
- Pentapharm GmbH
- Product code
- Code JPA
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munich, DE
Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
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.