510(k) K142080

NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED by Ecolab, Inc. — Product Code LHC

K142080 is an FDA 510(k) premarket notification submitted by Ecolab, Inc. for the device "NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED". The FDA issued a decision of Substantially Equivalent on August 28, 2014. The device falls under product code LHC (Warmer, Irrigation Solution), a Class I device regulated under 21 CFR 890.5950. Ecolab, Inc. has at least 6 other 510(k) clearances on record.