Device Classification Name |
Computer, Diagnostic, Programmable
|
510(k) Number |
K083639 |
Device Name |
MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
9900 INNOVATION DR. |
WAUWATOSA,
WI
53226
|
|
Applicant Contact |
LARRY LEPLEY |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
9900 INNOVATION DR. |
WAUWATOSA,
WI
53226
|
|
Correspondent Contact |
LARRY LEPLEY |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 12/09/2008 |
Decision Date | 02/17/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|