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510(k) K832945

EAGLE 2000 STERILIZER SERIES GAS/AERA by Amsco Co. — Product Code FLF

K832945 is an FDA 510(k) premarket notification submitted by Amsco Co. for the device "EAGLE 2000 STERILIZER SERIES GAS/AERA". The FDA issued a decision of Substantially Equivalent on October 19, 1983. The device falls under product code FLF (Sterilizer, Ethylene-Oxide Gas), a Class II device regulated under 21 CFR 880.6860. Amsco Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1983
Date Received
August 30, 1983
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 Amsco Co.

  • K912471 — EAGLE 3000 SDS (June 26, 1992)
  • K854922 — AMSCO POLARIS SL (January 24, 1986)
  • K833187 — HALL OSTEON (October 31, 1983)
  • K832188 — HALL RECIPROCATOR (August 12, 1983)
  • K831086 — CEILING MOUNTED SUPPORT (August 12, 1983)
  • K832186 — HALL DRILL/REAMER (August 12, 1983)
  • K832187 — HALL OSCILLATOR (August 12, 1983)
  • K831309 — DELIVERY 4 TABLE (June 15, 1983)
  • K823360 — SURGICAL LIGHT (December 3, 1982)
  • K811242 — DISPOSABLE STERILIZATION WRAP (May 21, 1981)

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)
  • 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)

FDA data resources