Clearance Summary
HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER received FDA 510(k) clearance under submission number K861505, sponsored by American Medical Equipment, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1987-04-10.
- Submission: K861505
- Applicant / Sponsor: American Medical Equipment, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1435
- Decision date: 1987-04-10
Classification & Regulation
This clearance is catalogued under FDA product code DXG and 21 CFR 870.1435, within the Cardiovascular review panel as a Class II device.