EOGas 4 Ethylene Oxide Gas Sterilizer
K-Number: K192978 · 2020-11-12
ApplicantAndersen Sterilizers, Inc.
Decision Date2020-11-12
Product CodeFLF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
EOGas 4 Ethylene Oxide Gas Sterilizer is a medical device manufactured by Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2020-11-12 under approval number K192978. The device is classified under product code FLF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EOGas 4 Ethylene Oxide Gas Sterilizer?
EOGas 4 Ethylene Oxide Gas Sterilizer is a medical device that received FDA 510(k) clearance on 2020-11-12. It is manufactured by Andersen Sterilizers, Inc.. The 510(k) number is K192978.
When was EOGas 4 Ethylene Oxide Gas Sterilizer approved by the FDA?
EOGas 4 Ethylene Oxide Gas Sterilizer received FDA 510(k) clearance on 2020-11-12, under approval number K192978.
What company makes EOGas 4 Ethylene Oxide Gas Sterilizer?
EOGas 4 Ethylene Oxide Gas Sterilizer is manufactured by Andersen Sterilizers, Inc..
What is the FDA product code for EOGas 4 Ethylene Oxide Gas Sterilizer?
The FDA product code for EOGas 4 Ethylene Oxide Gas Sterilizer is FLF.
Related PubMed Literature
Other Devices by Andersen Sterilizers, Inc.
Related Devices (Code: FLF)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.