Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K011404 |
Device Name |
FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS |
Applicant |
DRAEGER MEDICAL, INC. |
3135 QUARRY RD. |
TELFORD,
PA
18969
|
|
Applicant Contact |
MICHAIL A KELHART |
Correspondent |
DRAEGER MEDICAL, INC. |
3135 QUARRY RD. |
TELFORD,
PA
18969
|
|
Correspondent Contact |
MICHAIL A KELHART |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 05/08/2001 |
Decision Date | 02/22/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|