Device Classification Name |
filter, bacterial, breathing-circuit
|
510(k) Number |
K000654 |
Device Name |
VBMAX |
Applicant |
A-M SYSTEMS, INC. |
131 BUSINESS PARK LOOP |
P.O. BOX 850 |
CARLSBORG,
WA
98324
|
|
Applicant Contact |
STEVE GRASSER |
Correspondent |
A-M SYSTEMS, INC. |
131 BUSINESS PARK LOOP |
P.O. BOX 850 |
CARLSBORG,
WA
98324
|
|
Correspondent Contact |
STEVE GRASSER |
Regulation Number | 868.5260
|
Classification Product Code |
|
Date Received | 02/28/2000 |
Decision Date | 11/14/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|