Clearance Summary
PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 received FDA 510(k) clearance under submission number K113183, sponsored by Shanghai 3f Electronics Co, Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-02-09.
- Submission: K113183
- Applicant / Sponsor: Shanghai 3f Electronics Co, Ltd.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2012-02-09
Classification & Regulation
This clearance is catalogued under FDA product code MWI and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.