Device Classification Name |
Pump, Infusion
|
510(k) Number |
K173084 |
Device Name |
Spectrum IQ Infusion System, Dose IQ Safety Software |
Applicant |
Baxter Healthcare Corporation |
32650 N. Wilson Road |
Round Lake,
IL
60073
|
|
Applicant Contact |
Dhiraj Bizzul |
Correspondent |
Baxter Healthcare Corporation |
32650 N. Wilson Road |
Round Lake,
IL
60073
|
|
Correspondent Contact |
Dhiraj Bizzul |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/29/2017 |
Decision Date | 05/11/2018 |
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
|
Recalls |
CDRH Recalls
|
|
|