Clearance Summary
MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION received FDA 510(k) clearance under submission number K991786, sponsored by General Electric Medical Systems Information Techn. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-11-18.
- Submission: K991786
- Applicant / Sponsor: General Electric Medical Systems Information Techn
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 1999-11-18
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.