Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K812980 |
Device Name |
MA-2 VENTILATOR |
Applicant |
BIO-MEDICAL REPAIR, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
BIO-MEDICAL REPAIR, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 10/23/1981 |
Decision Date | 11/06/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|