Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K896380 |
Device Name |
IC-2A MRI ADULT/PEDIATRIC VENTILATOR |
Applicant |
BIO-MED DEVICES, INC. |
8 BISHOP LN. |
MADISON,
CT
06443
|
|
Applicant Contact |
DEAN J BENNETT |
Correspondent |
BIO-MED DEVICES, INC. |
8 BISHOP LN. |
MADISON,
CT
06443
|
|
Correspondent Contact |
DEAN J BENNETT |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 11/06/1989 |
Decision Date | 02/12/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|