Clearance Summary
ATOM INFA WARMER V-505 received FDA 510(k) clearance under submission number K002355, sponsored by Atom Medical Corp. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2000-10-10.
- Submission: K002355
- Applicant / Sponsor: Atom Medical Corp
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5130
- Decision date: 2000-10-10
Classification & Regulation
This clearance is catalogued under FDA product code FMT and 21 CFR 880.5130, within the General Hospital review panel as a Class II device.