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. Device class: 2.
Clearance details
- Applicant
- Pentapharm GmbH
- Product code
- Code JPA
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munich, DE
Recent devices under product code JPA
view allAdverse 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 →
Recalls naming K083842
K-number listed on FDA's recall record- Z-1090-2016 — ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.
- Z-1379-2015 — ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083842.
Data sourced from openFDA. This site is unofficial and independent of the FDA.