Clearance Summary
Accutorr 7/VS-900 Vital Signs Monitor received FDA 510(k) clearance under submission number K170712, sponsored by Shenzhen Mindray Bio-Meidcal Electronics 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 2017-08-02.
- Submission: K170712
- Applicant / Sponsor: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2017-08-02
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.