EOGas 4 Ethylene Oxide Gas Sterilizer— 510(k) K150646

Name: FDA 510(k) clearance K150646
Creator: U.S. Food and Drug Administration
Published: 2015-11-18

Substantially Equivalent

Andersen Sterilizers, Inc.

FDA 510(k) clearance K150646 for EOGas 4 Ethylene Oxide Gas Sterilizer, Substantially Equivalent on 2015-11-18. Applicant: Andersen Sterilizers, Inc.. Device class: 2.

Clearance details

Applicant: Andersen Sterilizers, Inc.
Product code: Code FLF
Device class: Class 2
Regulation: 21 CFR 880.6860
Advisory panel: General Hospital
Date received: 2015-03-12
Decision date: 2015-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haw River, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FLF

view all

K192978 — EOGas 4 Ethylene Oxide Gas Sterilizer2020-11-12
K170432 — Anprolene AN75 Ethylene Oxide Gas Sterilizer2017-10-31
K142034 — 3M STERI-VAC STERILIZER/AERATOR2015-01-08
K090636 — TSO3 OZONE STERILIZER, MODEL 125L2009-12-02
K051595 — TSO3 OZONE STERILIZER, MODEL 125L2006-07-26

More clearances from Andersen Sterilizers, Inc.

view all

K213296 — Anprolene SteriTest RRBI2022-04-12
K202879 — EOGas 4 Endo-SteriTest RRBI2021-03-03
K192980 — EOGas 4 Endo-SteriTest2020-11-12
K200334 — AN1036 Dosimeter2020-11-12
K200335 — Sterisheet Sterilization Wrap2020-11-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.