Clearance Summary
Monitor B125, Monitor B105 received FDA 510(k) clearance under submission number K171580, sponsored by Ge Medical Systems (China) 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 2017-11-01.
- Submission: K171580
- Applicant / Sponsor: Ge Medical Systems (China) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2017-11-01
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.