Clearance Summary
ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes received FDA 510(k) clearance under submission number K152522, sponsored by Ecolab, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2016-01-15.
- Submission: K152522
- Applicant / Sponsor: Ecolab, Inc.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5950
- Decision date: 2016-01-15
Classification & Regulation
This clearance is catalogued under FDA product code LHC and 21 CFR 890.5950, within the Physical Medicine review panel as a Class I device.