Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K051629 |
Device Name |
BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 |
Applicant |
BLEASE USA, INC. |
962 ALLEGRO LANE |
APOLLO BEACH,
FL
33572
|
|
Applicant Contact |
ARTHUR J WARD |
Correspondent |
BLEASE USA, INC. |
962 ALLEGRO LANE |
APOLLO BEACH,
FL
33572
|
|
Correspondent Contact |
ARTHUR J WARD |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 06/20/2005 |
Decision Date | 09/23/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|