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510(k) K152522

ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes by Ecolab, Inc. — Product Code LHC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2016
Date Received
September 3, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Irrigation Solution
Device Class
Class I
Regulation Number
890.5950
Review Panel
HO
Submission Type

Other clearances by Ecolab, Inc.

  • K182164 — Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Eco (March 29, 2019)
  • K173164 — Ecolab POU Water Filter (June 29, 2018)
  • K150190 — IntraTemp Solution Warmer (February 26, 2015)
  • K142173 — NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE (December 30, 2014)
  • K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE (August 28, 2014)
  • K883593 — #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY (September 30, 1988)

Other clearances for product code LHC

  • K153713 — Getinge Series Warming Cabinet (June 7, 2016)
  • K150190 — IntraTemp Solution Warmer (February 26, 2015)
  • K142173 — NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE (December 30, 2014)
  • K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE (August 28, 2014)
  • K083417 — INTRATEMP SOLUTION WARMER (January 13, 2009)
  • K080609 — SWC/DWC WARMING CABINETS (June 13, 2008)
  • K051819 — C CHANGE SOLUTION WARMER (August 15, 2005)
  • K023282 — ORS-3000LD (November 13, 2002)
  • K023283 — 1075LD HUSH-SLUSH (November 13, 2002)
  • K021288 — ORS-1000LD (June 27, 2002)