Device Classification Name |
gas-machine, anesthesia
|
510(k) Number |
K083098 |
Device Name |
NAVIGATOR APPLICATIONS SUITE |
Applicant |
GE HEALTHCARE FINLAND OY |
3030 OHMEDA DRIVE |
PO BOX 7550 |
MADISON,
WI
53707 -7550
|
|
Applicant Contact |
ADRIENNE LENZ |
Correspondent |
GE HEALTHCARE FINLAND OY |
3030 OHMEDA DRIVE |
PO BOX 7550 |
MADISON,
WI
53707 -7550
|
|
Correspondent Contact |
ADRIENNE LENZ |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 10/17/2008 |
Decision Date | 04/01/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|