Device Classification Name |
pump, infusion
|
510(k) Number |
K162613 |
Device Name |
Integrated Catch-up Freedom Syringe Driver Infusion System |
Applicant |
Repro-Med Systems, Inc., DBA RMS Medical Products |
24 Carpenter Road |
Chester,
NY
10918
|
|
Applicant Contact |
Fred Ma |
Correspondent |
Repro-Med Systems, Inc., DBA RMS Medical Products |
24 Carpenter Road |
Chester,
NY
10918
|
|
Correspondent Contact |
Fred Ma |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/19/2016 |
Decision Date | 08/31/2017 |
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
|
|
|