Clearance Summary
LIFENET SYSTEM received FDA 510(k) clearance under submission number K093925, sponsored by Physio-Control, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-01-12.
- Submission: K093925
- Applicant / Sponsor: Physio-Control, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2010-01-12
Classification & Regulation
This clearance is catalogued under FDA product code MSX and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.