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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2020-11-12 under 510(k) 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. The listed applicant is Andersen Sterilizers, Inc.. The 510(k) number is K192978.

When did EOGas 4 Ethylene Oxide Gas Sterilizer receive FDA 510(k) clearance?

EOGas 4 Ethylene Oxide Gas Sterilizer received FDA 510(k) clearance on 2020-11-12, under 510(k) number K192978.

Who is the listed applicant for EOGas 4 Ethylene Oxide Gas Sterilizer?

The FDA 510(k) record lists Andersen Sterilizers, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Andersen Sterilizers, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213296Anprolene SteriTest RRBIK202879EOGas 4 Endo-SteriTest RRBIK200336Tyvek Sterilization Pouches with Chevron SealK200335Sterisheet Sterilization WrapK200334AN1036 DosimeterK192980EOGas 4 Endo-SteriTest

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Related Devices (Code: FLF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170432Anprolene AN75 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.

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.

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