Clearance Summary
Reusable Full Silicone Cover received FDA 510(k) clearance under submission number K151702, sponsored by Laerdal Medical AS. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2015-08-13.
- Submission: K151702
- Applicant / Sponsor: Laerdal Medical AS
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5210
- Decision date: 2015-08-13
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.