Clearance Summary
CLUE MEDICAL AND CLUE MEDICAL BASIC received FDA 510(k) clearance under submission number K083630, sponsored by Telovital GmbH Telemedizin. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-04-23.
- Submission: K083630
- Applicant / Sponsor: Telovital GmbH Telemedizin
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2920
- Decision date: 2009-04-23
Classification & Regulation
This clearance is catalogued under FDA product code DXH and 21 CFR 870.2920, within the Cardiovascular review panel as a Class II device.