Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K921821 |
Device Name |
IBT MODEL SVI |
Applicant |
BIOMAGNETIC TECHNOLOGIES, INC. |
9021 45TH AVE N. |
NEWHOPE,
MN
55428
|
|
Applicant Contact |
MICHAEL J BOYLE |
Correspondent |
BIOMAGNETIC TECHNOLOGIES, INC. |
9021 45TH AVE N. |
NEWHOPE,
MN
55428
|
|
Correspondent Contact |
MICHAEL J BOYLE |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 04/16/1992 |
Decision Date | 11/02/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|