Device Classification Name |
warmer, thermal, infusion fluid
|
510(k) Number |
K163708 |
Device Name |
QiF Blood and Fluid Warmer |
Applicant |
Quality In Flow Ltd. |
Kibutz Einat POB 29 |
Kibutz Einat,
IL
4880500
|
|
Applicant Contact |
Neta Sherman |
Correspondent |
Quality in Flow Ltd. |
POB 29 |
Kibutz Einat,
IL
4880500
|
|
Correspondent Contact |
Neta Sherman |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/29/2016 |
Decision Date | 04/20/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|