Device Classification Name |
device, warming. blood and plasma
|
510(k) Number |
DK760012 |
Tradename |
Blood Warmer, Code 4R4305
|
Device Name |
Blood and Plasma Warming Devices |
Original Applicant |
Travenol Laboratories |
rt 120 and wilson rd. |
round lake,
IL
60073
|
|
Regulation Number | 864.9205
|
Classification Product Code |
|
Date Received | 06/10/1976 |
Decision Date | 07/16/1976 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Hematology
|
Review Advisory Committee |
Hematology
|
Type |
510(k) Traditional
|
Total Product Life Cycle (TPLC) |
TPLC Device Report
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
Combination Product |
No
|
In Vitro Product |
No
|
|
|