Clearance Summary
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 received FDA 510(k) clearance under submission number K000206, sponsored by Axelgaard Mfg. 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 2000-04-13.
- Submission: K000206
- Applicant / Sponsor: Axelgaard Mfg. Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 2000-04-13
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.