Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K071073 |
Device Name |
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
8200 WEST TOWER AVE. |
MILWAUKEE,
WI
53223
|
|
Applicant Contact |
KAREN M LUNDE |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
8200 WEST TOWER AVE. |
MILWAUKEE,
WI
53223
|
|
Correspondent Contact |
KAREN M LUNDE |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 04/16/2007 |
Decision Date | 05/11/2007 |
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
|
|
|