LHC · Class I · 21 CFR 890.5950

FDA Product Code LHC: Warmer, Irrigation Solution

Leading manufacturers include Ecolab, Inc., C Change Surgical, LLC and Mac Medical.

24
Total
24
Cleared
113d
Avg days
1981
Since

FDA 510(k) Cleared Warmer, Irrigation Solution Devices (Product Code LHC)

24 devices
1–24 of 24
Cleared Jun 07, 2016
Getinge Series Warming Cabinet
K153713
Getinge Sourcing, LLC
General Hospital · 166d
Cleared Jan 15, 2016
ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes
K152522
Ecolab, Inc.
General Hospital · 134d
Cleared Feb 26, 2015
IntraTemp Solution Warmer
K150190
Ecolab, Inc.
General Hospital · 30d
Cleared Dec 30, 2014
NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
K142173
Ecolab, Inc.
General Hospital · 145d
Cleared Aug 28, 2014
NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
K142080
Ecolab, Inc.
General Hospital · 28d
Cleared Jun 13, 2008
SWC/DWC WARMING CABINETS
K080609
Mac Medical
General Hospital · 102d
Cleared Aug 15, 2005
C CHANGE SOLUTION WARMER
K051819
C Change Surgical, LLC
General Hospital · 41d
Cleared Oct 16, 1998
UROSURGE UROTHERM FLUID WARMING SYSTEM
K965136
Princeton Regulatory Assoc.
General Hospital · 662d
Cleared Aug 22, 1997
WARMETTE
K971117
Olympic Medical Corp.
General Hospital · 148d
Cleared Jun 20, 1995
NEZHAT-DORSEY THERMAL RETENTION SYSTEM
K951300
American Hydro-Surgical Instruments, Inc.
General Hospital · 90d
Cleared Feb 22, 1994
CABOT MEDICAL IRRIGATION FLUID WARMER SETS
K932538
Cabot Medical Corp.
General Hospital · 272d
Cleared Jan 28, 1994
MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM
K933726
Augustine Medical, Inc.
General Hospital · 179d
Cleared Jun 02, 1992
ORS-2000 SERIES
K921633
Mnlase, Inc.
General Hospital · 57d
Cleared Jul 01, 1981
AQUACADE
K811524
Respiratory Care, Inc.
General Hospital · 33d

About Product Code LHC - Regulatory Context