Clearance Summary
ALCATEL-LUCENT TELEHEATH MANAGER received FDA 510(k) clearance under submission number K092635, sponsored by Alcatel-Lucent Canada, 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 2009-09-10.
- Submission: K092635
- Applicant / Sponsor: Alcatel-Lucent Canada, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2009-09-10
Classification & Regulation
This clearance is catalogued under FDA product code DRG and 21 CFR 870.2910, within the Cardiovascular review panel as a Class II device.