Device Classification Name |
Pump, Infusion
|
510(k) Number |
K183311 |
Device Name |
Ivenix Infusion System (IIS) |
Applicant |
Ivenix, Inc. |
50 High St., Suite 50 |
North Andover,
MA
01845
|
|
Applicant Contact |
John J. Sokolowski |
Correspondent |
Ivenix, Inc. |
50 High St., Suite 50 |
North Andover,
MA
01845
|
|
Correspondent Contact |
John J. Sokolowski |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/29/2018 |
Decision Date | 06/07/2019 |
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
|
Recalls |
CDRH Recalls
|
|
|