Clearance Summary
LULLABY TM WARMER received FDA 510(k) clearance under submission number K121625, sponsored by Wipro GE Healthcare Private, 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 2012-09-14.
- Submission: K121625
- Applicant / Sponsor: Wipro GE Healthcare Private, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5130
- Decision date: 2012-09-14
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.