Clearance Summary
Infant Transport Mattress Warmer with Disc received FDA 510(k) clearance under submission number K163295, sponsored by Rapid Aid Corp.. 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 2017-07-24.
- Submission: K163295
- Applicant / Sponsor: Rapid Aid Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5710
- Decision date: 2017-07-24
Classification & Regulation
This clearance is catalogued under FDA product code IMD and 21 CFR 890.5710, within the Physical Medicine review panel as a Class I device.