Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K073462 |
Device Name |
MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
86 PILGRIN RD. |
NEEDHAM,
MA
02492
|
|
Applicant Contact |
JOEL KENT |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
86 PILGRIN RD. |
NEEDHAM,
MA
02492
|
|
Correspondent Contact |
JOEL KENT |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 12/10/2007 |
Decision Date | 01/11/2008 |
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
|
|
|