Clearance Summary
CPRMETER CPR FEEDBACK DEVICE received FDA 510(k) clearance under submission number K122050, sponsored by Laerdal Medical A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-10-22.
- Submission: K122050
- Applicant / Sponsor: Laerdal Medical A/S
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5210
- Decision date: 2012-10-22
Classification & Regulation
This clearance is catalogued under FDA product code LIX and 21 CFR 870.5210, within the Cardiovascular review panel as a Class II device.