Device Classification Name |
pump, infusion
|
510(k) Number |
K222048 |
Device Name |
Spectrum IQ Infusion System with Dose IQ Safety Software |
Applicant |
Baxter Healthcare Corporation |
25212 W. Illinois Route 120 |
Round Lake,
IL
60073
|
|
Applicant Contact |
Jennifer Hoogheem |
Correspondent |
Baxter Healthcare Corporation |
25212 W. Illinois Route 120 |
Round Lake,
IL
60073
|
|
Correspondent Contact |
Jennifer Hoogheem |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/12/2022 |
Decision Date | 09/06/2022 |
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
|
|
|