Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K982137 |
Device Name |
BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE |
Applicant |
BLEASE MEDICAL EQUIPMENT LTD. |
12601 RESEARCH PKWY. |
ATT: FRANCIS X CASEY |
ORLANDO,
FL
32826
|
|
Applicant Contact |
FRANCIS X CASEY |
Correspondent |
BLEASE MEDICAL EQUIPMENT LTD. |
12601 RESEARCH PKWY. |
ATT: FRANCIS X CASEY |
ORLANDO,
FL
32826
|
|
Correspondent Contact |
FRANCIS X CASEY |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 06/17/1998 |
Decision Date | 04/09/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|