FOA — Board, Cardiopulmonary Class I

FDA Device Classification

FDA product code FOA covers "Board, Cardiopulmonary", a Class I medical device regulated under 21 CFR 880.6080. Submissions are reviewed by the General Hospital panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FOA
Device Class
Class I
Regulation Number
880.6080
Submission Type
510(k) Exempt
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K221901Advancedcpr SolutionsEleGARDJul 29, 2022
K191689Minnesota Resuscitation Solutions, D.B.D Advancedcpr SolutioEleGARD Patient Positioning SystemFeb 13, 2020
K811397GillcoECAJul 2, 1981