Clearance Summary
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 received FDA 510(k) clearance under submission number K053011, sponsored by Bio Protech, 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 2005-12-14.
- Submission: K053011
- Applicant / Sponsor: Bio Protech, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 2005-12-14
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.