Clearance Summary
SLIMMANAGER, MODEL SM-X, SM-E received FDA 510(k) clearance under submission number K051589, sponsored by Aiia Communication, 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 2005-10-31.
- Submission: K051589
- Applicant / Sponsor: Aiia Communication, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2005-10-31
Classification & Regulation
This clearance is catalogued under FDA product code MNW and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.