Clearance Summary
12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 received FDA 510(k) clearance under submission number K050074, sponsored by Welch Allyn, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2005-03-22.
- Submission: K050074
- Applicant / Sponsor: Welch Allyn, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2005-03-22
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.