Clearance Summary
EleGARD received FDA 510(k) clearance under submission number K221901, sponsored by Advancedcpr Solutions, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2022-07-29.
- Submission: K221901
- Applicant / Sponsor: Advancedcpr Solutions, LLC
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6080
- Decision date: 2022-07-29
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.