K221901 is an FDA 510(k) clearance for the EleGARD. This device is classified as a Board, Cardiopulmonary (Class I - General Controls, product code FOA).
Submitted by Advancedcpr Solutions, LLC (Edina, US). The FDA issued a Cleared decision on July 29, 2022, 29 days after receiving the submission on June 30, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6080.
| 510(k) Number | K221901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2022 |
| Decision Date | July 29, 2022 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOA - Board, Cardiopulmonary |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6080 |