FDA Product Code FOA: Board, Cardiopulmonary
Leading manufacturers include Advancedcpr Solutions, LLC.
3
Total
3
Cleared
102d
Avg days
1981
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Board, Cardiopulmonary Devices (Product Code FOA)
3 devices
About Product Code FOA - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code FOA since 1981, with 3 receiving FDA clearance (average review time: 102 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
FOA devices are reviewed by the General Hospital panel. Browse all General Hospital devices →