Clearance Summary
LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE received FDA 510(k) clearance under submission number K101331, sponsored by C.R. Bard Inc., Bard Electrophysiology Division. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-10-08.
- Submission: K101331
- Applicant / Sponsor: C.R. Bard Inc., Bard Electrophysiology Division
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2010-10-08
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.