Device Classification Name |
spirometer, monitoring (w/wo alarm)
|
510(k) Number |
K822912 |
Device Name |
BEAR VM-90 VENTILATION MONITOR |
Applicant |
BEAR MEDICAL SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
BEAR MEDICAL SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.1850
|
Classification Product Code |
|
Date Received | 10/01/1982 |
Decision Date | 11/16/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|