The following data is part of a premarket notification filed by Pentapharm Gmbh with the FDA for Rotem Delta Thromboelastometry System.
| Device ID | K083842 |
| 510k Number | K083842 |
| Device Name: | ROTEM DELTA THROMBOELASTOMETRY SYSTEM |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | PENTAPHARM GMBH STAHLGRUBERRING 12 Munich, DE D-81829 |
| Contact | Volker Joachim Friemert |
| Correspondent | Volker Joachim Friemert PENTAPHARM GMBH STAHLGRUBERRING 12 Munich, DE D-81829 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-24 |
| Decision Date | 2010-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260160470587 | K083842 | 000 |
| 04260160470112 | K083842 | 000 |
| 04260160470105 | K083842 | 000 |
| 04260160470099 | K083842 | 000 |
| 04260160470082 | K083842 | 000 |
| 04260160470044 | K083842 | 000 |
| 04260160470020 | K083842 | 000 |