510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
FOAClass I

Board, Cardiopulmonary

21 CFR 880.6080 / General Hospital
FDA source (opens on fda.gov)

FOA is the FDA product code for Board, Cardiopulmonary, a class I device type, regulated under 21 CFR 880.6080. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FOA
Device name
Board, Cardiopulmonary
Regulation
21 CFR 880.6080
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code FOA

By decision year
3 clearances under product code FOA with a decision year between 1981 and 2022, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FOA by decision year
YearClearances
19811
20201
20221

Applicants with the most clearances

Product code FOA
Applicants holding the most 510(k) clearances under product code FOA
ApplicantClearances
Advancedcpr Solutions, LLC1
Gillco, Inc.1
Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order