Device Classification Name |
pump, infusion
|
510(k) Number |
K211206 |
Device Name |
FreedomEdge(R) Syringe Infusion System |
Applicant |
Repro-Medical System, Inc., dba Koru Medical Systems |
24 Carpenter Road |
Chester,
NY
10918
|
|
Applicant Contact |
Brian Schiller |
Correspondent |
Repro-Medical System, Inc., dba Koru Medical Systems |
24 Carpenter Road |
Chester,
NY
10918
|
|
Correspondent Contact |
Kachi Eniyinna |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/22/2021 |
Decision Date | 11/09/2021 |
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
|
|
|