Board, Cardiopulmonary
The Cardiopulmonary Board is a rigid support placed beneath a patient on a hospital bed or stretcher to provide a firm surface for performing cardiopulmonary resuscitation (CPR) effectively. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FOA, regulated under 21 CFR 880.6080 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- FOA
- Device Class
- FDA class 1
- Regulation Number
- 880.6080
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K221901 | EleGARD | Jul 29, 2022 | Substantially Equivalent | Advancedcpr Solutions, LLC |
| K191689 | EleGARD Patient Positioning System | Feb 13, 2020 | Substantially Equivalent | Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio |
| K811397 | ECA | Jul 02, 1981 | Substantially Equivalent | Gillco, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.