Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K091594 |
Device Name |
HEART-EXERCISE |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Applicant Contact |
PATRICIA TAIGE |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Correspondent Contact |
PATRICIA TAIGE |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/02/2009 |
Decision Date | 07/29/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|