Clearance Summary
Switched Internal Paddles received FDA 510(k) clearance under submission number K203231, sponsored by Philips North America, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-01-11.
- Submission: K203231
- Applicant / Sponsor: Philips North America, LLC
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5300
- Decision date: 2021-01-11
Classification & Regulation
This clearance is catalogued under FDA product code LDD and 21 CFR 870.5300, within the Cardiovascular review panel as a Class II device.