Clearance Summary
M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound received FDA 510(k) clearance under submission number K172970, sponsored by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2017-10-25.
- Submission: K172970
- Applicant / Sponsor: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2017-10-25
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.