Clearance Summary
IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP 0001 received FDA 510(k) clearance under submission number K060504, sponsored by Ideal Life, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-03-14.
- Submission: K060504
- Applicant / Sponsor: Ideal Life, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2006-03-14
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.