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FDA 510(k)

EOGas 4 Endo-SteriTest RRBI

K-Number: K202879 · 2021-03-03

Decision Date2021-03-03
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EOGas 4 Endo-SteriTest RRBI 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 2021-03-03 under 510(k) number K202879. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EOGas 4 Endo-SteriTest RRBI?

EOGas 4 Endo-SteriTest RRBI is a medical device that received FDA 510(k) clearance on 2021-03-03. The listed applicant is Andersen Sterilizers, Inc.. The 510(k) number is K202879.

When did EOGas 4 Endo-SteriTest RRBI receive FDA 510(k) clearance?

EOGas 4 Endo-SteriTest RRBI received FDA 510(k) clearance on 2021-03-03, under 510(k) number K202879.

Who is the listed applicant for EOGas 4 Endo-SteriTest RRBI?

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 Endo-SteriTest RRBI?

The FDA product code for EOGas 4 Endo-SteriTest RRBI is FRC.

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.

View all 13 devices →

Related Devices (Code: FRC)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.