Clearance Summary
EleGARD Patient Positioning System received FDA 510(k) clearance under submission number K191689, sponsored by Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2020-02-13.
- Submission: K191689
- Applicant / Sponsor: Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6080
- Decision date: 2020-02-13
Classification & Regulation
This clearance is catalogued under FDA product code FOA and 21 CFR 880.6080, within the General Hospital review panel as a Class I device.