Clearance Summary
HEALTH MANAGER, VERSION 1.1 received FDA 510(k) clearance under submission number K081499, sponsored by Biocomfort Diagnostics GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-01-16.
- Submission: K081499
- Applicant / Sponsor: Biocomfort Diagnostics GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2009-01-16
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.