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510(k) K051595

TSO3 OZONE STERILIZER, MODEL 125L by Tso3, Inc. — Product Code FLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2006
Date Received
June 16, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Ethylene-Oxide Gas
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

Other clearances by Tso3, Inc.

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  • K172191 — STERIZONE VP4 Sterilizer (May 9, 2018)
  • K173694 — STERIZONE VP4 Sterilizer (March 13, 2018)
  • K153689 — STERIZONE Sterilizer (June 30, 2016)
  • K141163 — STERIZONE STERILIZER (December 17, 2014)
  • K141698 — STERIZONE CHEMICAL INDICATOR (December 17, 2014)
  • K141580 — STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR (December 17, 2014)
  • K090636 — TSO3 OZONE STERILIZER, MODEL 125L (December 2, 2009)
  • K080198 — TSO3 OZONE STERILIZATION WRAP (May 30, 2008)

Other clearances for product code FLF

  • K192978 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 12, 2020)
  • K170432 — Anprolene AN75 Ethylene Oxide Gas Sterilizer (October 31, 2017)
  • K150646 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 18, 2015)
  • K142034 — 3M STERI-VAC STERILIZER/AERATOR (January 8, 2015)
  • K090636 — TSO3 OZONE STERILIZER, MODEL 125L (December 2, 2009)
  • K020875 — TSO3 OZONE STERILIZER, MODEL 125L (August 26, 2003)
  • K014013 — H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (June 25, 2003)
  • K023290 — STERRAD 50 & STERRAD 100S STERILIZERS (April 3, 2003)
  • K923442 — ABTOX PLAZLYTE PROCESS MONITOR (December 22, 1994)
  • K905119 — PLAZLYTE(TM) (December 22, 1994)