Clearance Summary
Nurture Rest received FDA 510(k) clearance under submission number K172962, sponsored by Neonatal Loving Kare, Inc.. 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 2018-01-18.
- Submission: K172962
- Applicant / Sponsor: Neonatal Loving Kare, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5680
- Decision date: 2018-01-18
Classification & Regulation
This clearance is catalogued under FDA product code OUW and 21 CFR 880.5680, within the General Hospital review panel as a Class I device.