Device Classification Name |
transmitters and receivers, physiological signal, radiofrequency
|
510(k) Number |
K120470 |
Device Name |
MIPAL |
Applicant |
WATERMARK MEDICAL |
12715 FALCON DRIVE |
BROOKFIELD,
WI
53005
|
|
Applicant Contact |
MICHAEL J LEIGH |
Correspondent |
WATERMARK MEDICAL |
12715 FALCON DRIVE |
BROOKFIELD,
WI
53005
|
|
Correspondent Contact |
MICHAEL J LEIGH |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 02/16/2012 |
Decision Date | 06/08/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|