Clearance Summary
H59 CRITICAL CARE MONITOR received FDA 510(k) clearance under submission number K791839, 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 1979-10-01.
- Submission: K791839
- Applicant / Sponsor: Medtel Pty. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1110
- Decision date: 1979-10-01
Classification & Regulation
This clearance is catalogued under FDA product code DSK and 21 CFR 870.1110, within the Cardiovascular review panel as a Class II device.