Clearance Summary
MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP) received FDA 510(k) clearance under submission number K062127, sponsored by Medic4all (Israel) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-11-08.
- Submission: K062127
- Applicant / Sponsor: Medic4all (Israel) , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2006-11-08
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.