Clearance Summary
SABRATEK PATIENT HOME MANAGEMENT SYSTEM received FDA 510(k) clearance under submission number K980619, sponsored by Sabratek Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-08-20.
- Submission: K980619
- Applicant / Sponsor: Sabratek Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1998-08-20
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.