Clearance Summary
Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) received FDA 510(k) clearance under submission number K151845, sponsored by CooperSurgical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2016-03-18.
- Submission: K151845
- Applicant / Sponsor: CooperSurgical, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5710
- Decision date: 2016-03-18
Classification & Regulation
This clearance is catalogued under FDA product code MPO and 21 CFR 890.5710, within the Physical Medicine review panel as a Class I device.