Device Classification Name |
pump, infusion, elastomeric
|
510(k) Number |
K131247 |
Device Name |
MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM |
Applicant |
MFS - MEDICAL FLOW SYSTEMS LTD |
ELT BUILDING, DORA INDUSTRIAL ZONE, SHLOMI 22832, ISRAL |
SHLOMI,
IL
22832
|
|
Applicant Contact |
OFER SHAY |
Correspondent |
MFS - MEDICAL FLOW SYSTEMS LTD |
ELT BUILDING, DORA INDUSTRIAL ZONE, SHLOMI 22832, ISRAL |
SHLOMI,
IL
22832
|
|
Correspondent Contact |
OFER SHAY |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/01/2013 |
Decision Date | 08/14/2013 |
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
|
|
|