Clearance Summary
PALM ECG RECORDER, MODEL EP-201/202 received FDA 510(k) clearance under submission number K061123, sponsored by Parama-Tech Company., 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 2007-06-29.
- Submission: K061123
- Applicant / Sponsor: Parama-Tech Company., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2007-06-29
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.