Device Classification Name |
ventilator, emergency, manual (resuscitator)
|
510(k) Number |
K802231 |
Device Name |
AIR VIVA II |
Applicant |
GENERAL MEDICAL CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
GENERAL MEDICAL CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 09/15/1980 |
Decision Date | 10/10/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|