FDA Product Code FOA: Board, Cardiopulmonary
Leading manufacturers include Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio and 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
Cleared
Jul 29, 2022
EleGARD
Advancedcpr Solutions, LLC
General Hospital
29d
Cleared
Feb 13, 2020
EleGARD Patient Positioning System
Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio
General Hospital
233d
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.