Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K801697 |
Device Name |
MODEL BP-200 INFANT PRESSURE VENTILATOR |
Applicant |
BOURNS MEDICAL SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
BOURNS MEDICAL SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 07/23/1980 |
Decision Date | 08/07/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|