Clearance Summary
NEONATAL ECG ELECTRODE, M203KEN received FDA 510(k) clearance under submission number K092744, sponsored by R & D Medical Products, 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 2009-12-10.
- Submission: K092744
- Applicant / Sponsor: R & D Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 2009-12-10
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.