Device Classification Name |
device, warming. blood and plasma
|
510(k) Number |
BK860023 |
Tradename |
Level 1 Fluid Warmer
|
Device Name |
Device, Warming, Blood and Plasma |
Original Applicant |
Level 1 Technologies, Inc. |
160 weymouth street |
rockland,
MA
02370
|
|
Regulation Number | 864.9205
|
Classification Product Code |
|
Date Received | 05/08/1986 |
Decision Date | 09/25/1986 |
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
|
|
|