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510(k) K153713

Getinge Series Warming Cabinet by Getinge Sourcing, LLC — Product Code LHC

K153713 is an FDA 510(k) premarket notification submitted by Getinge Sourcing, LLC for the device "Getinge Series Warming Cabinet". The FDA issued a decision of Substantially Equivalent on June 7, 2016. The device falls under product code LHC (Warmer, Irrigation Solution), a Class I device regulated under 21 CFR 890.5950. Getinge Sourcing, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2016
Date Received
December 24, 2015
Clearance Type
Traditional
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 Getinge Sourcing, LLC

  • K122625 — GETINGE 800HC- SERIES STEAM STERILIZER (May 22, 2013)
  • K120532 — GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM (May 2, 2013)
  • K122071 — GETINGE 400HC-E / SERIES STEAM STERILIZER (March 12, 2013)
  • K120441 — GETINGE 700HC-E SERIES STEAM STERILIZER (May 31, 2012)
  • K103504 — GETINGE 400HC/500HC SERIES STEAM STERILIZER (March 16, 2011)
  • K070657 — GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER (April 5, 2007)

Other clearances for product code LHC

  • K152522 — ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes (January 15, 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)
  • K023283 — 1075LD HUSH-SLUSH (November 13, 2002)
  • K023282 — ORS-3000LD (November 13, 2002)
  • K021288 — ORS-1000LD (June 27, 2002)

FDA data resources