Clearance Summary
MAC 800 Resting ECG Analysis System received FDA 510(k) clearance under submission number K142288, sponsored by Ge Medical Systems China Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-12-03.
- Submission: K142288
- Applicant / Sponsor: Ge Medical Systems China Co., Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2014-12-03
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.