Clearance Summary
PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS received FDA 510(k) clearance under submission number K844176, sponsored by Premie Comfort Products. 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 1985-01-23.
- Submission: K844176
- Applicant / Sponsor: Premie Comfort Products
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5680
- Decision date: 1985-01-23
Classification & Regulation
This clearance is catalogued under FDA product code FRP and 21 CFR 880.5680, within the General Hospital review panel as a Class I device.