Device Classification Name |
Electrocardiograph
|
510(k) Number |
K093211 |
Device Name |
CARECENTER MD |
Applicant |
CARDIAC SCIENCE CORPORATION |
3303 MONTE VILLA PKWY. |
BOTHELL,
WA
98021
|
|
Applicant Contact |
THERESA MYERS |
Correspondent |
CARDIAC SCIENCE CORPORATION |
3303 MONTE VILLA PKWY. |
BOTHELL,
WA
98021
|
|
Correspondent Contact |
THERESA MYERS |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 10/13/2009 |
Decision Date | 06/03/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|