Device Classification Name |
system, multipurpose for in vitro coagulation studies
|
510(k) Number |
K101533 |
Device Name |
EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM |
Applicant |
Tem Innovations GmbH |
MARTIN-KOLLAR STR 13-15 |
MUNICH, BAVARIA/UPPER BAVARIA,
DE
81829
|
|
Applicant Contact |
VOLKER-JOACHIM FRIEMERT |
Correspondent |
Tem Innovations GmbH |
MARTIN-KOLLAR STR 13-15 |
MUNICH, BAVARIA/UPPER BAVARIA,
DE
81829
|
|
Correspondent Contact |
VOLKER-JOACHIM FRIEMERT |
Regulation Number | 864.5425
|
Classification Product Code |
|
Date Received | 06/03/2010 |
Decision Date | 08/10/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|