Clearance Summary
MODIFICATION TO ENVOY PATIENT MONITOR received FDA 510(k) clearance under submission number K011784, sponsored by Mennen Medical , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-08-16.
- Submission: K011784
- Applicant / Sponsor: Mennen Medical , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2001-08-16
Classification & Regulation
This clearance is catalogued under FDA product code DSI and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.