Device Classification Name |
system, network and communication, physiological monitors
|
510(k) Number |
K052972 |
Device Name |
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 |
Applicant |
GE HEALTHCARE |
86 PILGRIM ROAD |
NEEDHAM,
MA
02492
|
|
Applicant Contact |
JOEL KENT |
Correspondent |
GE HEALTHCARE |
86 PILGRIM ROAD |
NEEDHAM,
MA
02492
|
|
Correspondent Contact |
JOEL KENT |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 10/24/2005 |
Decision Date | 12/29/2005 |
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
|
|
|