Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K981530 |
Device Name |
SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM |
Applicant |
SPACELABS MEDICAL, INC. |
P.O. BOX 97013 |
REDMOND,
WA
98073 -9713
|
|
Applicant Contact |
RUSS GARRISON |
Correspondent |
SPACELABS MEDICAL, INC. |
P.O. BOX 97013 |
REDMOND,
WA
98073 -9713
|
|
Correspondent Contact |
RUSS GARRISON |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 04/29/1998 |
Decision Date | 11/20/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|