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FDA 510(k)

EOGas 4 Endo-SteriTest RRBI

K-Number: K202879 · 2021-03-03

ApplicantAndersen Sterilizers, Inc.
Decision Date2021-03-03
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EOGas 4 Endo-SteriTest RRBI is a medical device manufactured by Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2021-03-03 under approval 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. It is manufactured by Andersen Sterilizers, Inc.. The 510(k) number is K202879.

When was EOGas 4 Endo-SteriTest RRBI approved by the FDA?

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

What company makes EOGas 4 Endo-SteriTest RRBI?

EOGas 4 Endo-SteriTest RRBI is manufactured by Andersen Sterilizers, Inc..

What is the FDA product code for EOGas 4 Endo-SteriTest RRBI?

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

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Related Devices (Code: FRC)

K1605463M Attest Rapid Readout Biological Indicator3M Company K151482BCR-30-min BI™ and RBIP-ST30™ Readout AccessoryBcr Diagnostics, Inc. K172474Celerity 20 HP Biological IndicatorSTERIS Corporation K172432SporView Rapid Read Biological IndicatorCrosstex/Spsmedical, A Division of Cantel Medical K163646Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader IncubatorTerragene S.A. K170427Anprolene SteriTestAndersen 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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