Clearance Summary
INFANT RADIANT WARMER - MODELS IW910 AND IW920 received FDA 510(k) clearance under submission number K970432, sponsored by Fisher & Paykel Electronics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1997-05-07.
- Submission: K970432
- Applicant / Sponsor: Fisher & Paykel Electronics , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5130
- Decision date: 1997-05-07
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.