Home / Device Classification / LHC

LHC — Warmer, Irrigation Solution Class I

FDA Device Classification

Classification Details

Product Code
LHC
Device Class
Class I
Regulation Number
890.5950
Submission Type
Review Panel
HO
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K153713getinge sourcingGetinge Series Warming CabinetJune 7, 2016
K152522ecolabORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesJanuary 15, 2016
K150190ecolabIntraTemp Solution WarmerFebruary 26, 2015
K142173ecolabNON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPEDecember 30, 2014
K142080ecolabNON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE August 28, 2014
K083417c change surgicalINTRATEMP SOLUTION WARMERJanuary 13, 2009
K080609mac medicalSWC/DWC WARMING CABINETSJune 13, 2008
K051819c change surgicalC CHANGE SOLUTION WARMERAugust 15, 2005
K023283o.r. solutions1075LD HUSH-SLUSHNovember 13, 2002
K023282o.r. solutionsORS-3000LDNovember 13, 2002
K021288o.r. solutionsORS-1000LDJune 27, 2002
K021289o.r. solutionsWARMER 2000LDJune 26, 2002
K002859kmi kolster methodsSSW-STERILE SOLUTION WARMERNovember 16, 2000
K965136princeton regulatory assocUROSURGE UROTHERM FLUID WARMING SYSTEMOctober 16, 1998
K971117olympic medicalWARMETTEAugust 22, 1997
K951300american hydro-surgical instrumentsNEZHAT-DORSEY THERMAL RETENTION SYSTEMJune 20, 1995
K932538cabot medicalCABOT MEDICAL IRRIGATION FLUID WARMER SETSFebruary 22, 1994
K933726augustine medicalMODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEMJanuary 28, 1994
K921633mnlaseORS-2000 SERIESJune 2, 1992
K880876sonne medicalC-STAT/1000May 20, 1988