Clearance Summary
ECG SERIES ELECTROCARDIOGRAPH received FDA 510(k) clearance under submission number K111805, sponsored by Advanced Instrumentations, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-08-24.
- Submission: K111805
- Applicant / Sponsor: Advanced Instrumentations, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2011-08-24
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.