K191689 is an FDA 510(k) clearance for the EleGARD Patient Positioning System. This device is classified as a Board, Cardiopulmonary (Class I - General Controls, product code FOA).
Submitted by Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio (Edina, US). The FDA issued a Cleared decision on February 13, 2020, 233 days after receiving the submission on June 25, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6080.
| 510(k) Number | K191689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2019 |
| Decision Date | February 13, 2020 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| 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 |