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510(k) K020875

TSO3 OZONE STERILIZER, MODEL 125L by Technologies of Sterilization With Oxone, Tso3, Inc. — Product Code FLF

K020875 is an FDA 510(k) premarket notification submitted by Technologies of Sterilization With Oxone, Tso3, Inc. for the device "TSO3 OZONE STERILIZER, MODEL 125L". The FDA issued a decision of Substantially Equivalent on August 26, 2003. The device falls under product code FLF (Sterilizer, Ethylene-Oxide Gas), a Class II device regulated under 21 CFR 880.6860. Technologies of Sterilization With Oxone, Tso3, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2003
Date Received
March 18, 2002
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 Technologies of Sterilization With Oxone, Tso3, Inc.

  • K021161 — TSO3 OZONE CHEMICAL INDICATOR (August 27, 2003)

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)
  • K051595 — TSO3 OZONE STERILIZER, MODEL 125L (July 26, 2006)
  • K014013 — H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (June 25, 2003)
  • K023290 — STERRAD 50 & STERRAD 100S STERILIZERS (April 3, 2003)
  • K905119 — PLAZLYTE(TM) (December 22, 1994)
  • K923442 — ABTOX PLAZLYTE PROCESS MONITOR (December 22, 1994)

FDA data resources