Clearance Summary
BIS MODULE FOR ENVOY PATIENT MONITOR received FDA 510(k) clearance under submission number K071899, sponsored by Mennen Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2007-10-22.
- Submission: K071899
- Applicant / Sponsor: Mennen Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2007-10-22
Classification & Regulation
This clearance is catalogued under FDA product code OLW and 21 CFR 882.1400, within the Neurology review panel as a Class II device.