Clearance Summary
C50 and C80 Multi-parameter Patient Monitor received FDA 510(k) clearance under submission number K191106, sponsored by Shenzhen Comen Medical Instruments Co.,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 2019-12-13.
- Submission: K191106
- Applicant / Sponsor: Shenzhen Comen Medical Instruments Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2019-12-13
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.