Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K072502 |
Device Name |
MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
9900 INNAVATION DR. |
WAUWATOSA,
WI
53226
|
|
Applicant Contact |
PATRICIA TAIGE |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
9900 INNAVATION DR. |
WAUWATOSA,
WI
53226
|
|
Correspondent Contact |
PATRICIA TAIGE |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 09/06/2007 |
Decision Date | 11/19/2007 |
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
|
|
|