Clearance Summary
HS20 PORT. OPERATING ROOM MONITOR received FDA 510(k) clearance under submission number K820399, sponsored by Medtel Pty. , 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 1982-03-22.
- Submission: K820399
- Applicant / Sponsor: Medtel Pty. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1982-03-22
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.