Clearance Summary
HANDHELD ECG MONITOR, MODEL MD100 received FDA 510(k) clearance under submission number K080933, sponsored by Beijing Choice Electronic Technololgy 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 2008-09-26.
- Submission: K080933
- Applicant / Sponsor: Beijing Choice Electronic Technololgy Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2008-09-26
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.