510(k) K083842
K083842 is an FDA 510(k) premarket notification submitted by Pentapharm GmbH for the device "ROTEM DELTA THROMBOELASTOMETRY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 23, 2010. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Pentapharm GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2010
- Date Received
- December 24, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Multipurpose For In Vitro Coagulation Studies
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type