Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K070706 |
Device Name |
EP-WORKMATE |
Applicant |
EP MEDSYSTEMS |
COOPER RUN EXECUTIVE PARK |
575 ROUTE 73 N. BLDG. D |
WEST BERLIN,
NJ
08091
|
|
Applicant Contact |
LARRY PICCIANO |
Correspondent |
EP MEDSYSTEMS |
COOPER RUN EXECUTIVE PARK |
575 ROUTE 73 N. BLDG. D |
WEST BERLIN,
NJ
08091
|
|
Correspondent Contact |
LARRY PICCIANO |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 03/14/2007 |
Decision Date | 04/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|