FOA · Board, Cardiopulmonary
General Hospital · 21 CFR 880.6080 · Class 1
Overview
| Product Code | FOA |
|---|---|
| Device Name | Board, Cardiopulmonary |
| Regulation | 21 CFR 880.6080 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A cardiopulmonary resuscitation board is a device consisting of a rigid board which is placed under a patient to act as a support during cardiopulmonary resuscitation.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221901 | EleGARD | Advancedcpr Solutions, LLC | Jul 29, 2022 | SESE |
| K191689 | EleGARD Patient Positioning System | Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio | Feb 13, 2020 | SESE |
| K811397 | ECA | Gillco, Inc. | Jul 2, 1981 | SESE |
Top Applicants
- Advancedcpr Solutions, LLC — 1 clearance
- Gillco, Inc. — 1 clearance
- Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio — 1 clearance
