Device Classification Name |
pump, infusion
|
510(k) Number |
K172653 |
Device Name |
Power Infuser |
Applicant |
ZOLL Medical Corporation |
269 & 271 Mill Road |
Chelmsford,
MA
01824 -4105
|
|
Applicant Contact |
Pooja Dalvi |
Correspondent |
ZOLL Medical Corporation |
269 & 271 Mill Road |
Chelmsford,
MA
01824 -4105
|
|
Correspondent Contact |
Pooja Dalvi |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 09/05/2017 |
Decision Date | 07/18/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|