Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K093976 |
Device Name |
RAISIN PERSONAL MONITOR |
Applicant |
PROTEUS BIOMEDICAL, INC. |
2600 BRIDGE PARKWAY |
SUITE 101 |
REDWOOD CITY,
CA
94065
|
|
Applicant Contact |
GREGORY MOON |
Correspondent |
PROTEUS BIOMEDICAL, INC. |
2600 BRIDGE PARKWAY |
SUITE 101 |
REDWOOD CITY,
CA
94065
|
|
Correspondent Contact |
GREGORY MOON |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 12/24/2009 |
Decision Date | 03/25/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|