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FDA 510(k)

AN85/AN86 EO Indicators

K-Number: K170426 · 2017-10-30

ApplicantAndersen Sterilizers, Inc.
Decision Date2017-10-30
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AN85/AN86 EO Indicators is a medical device manufactured by Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2017-10-30 under approval number K170426. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AN85/AN86 EO Indicators?

AN85/AN86 EO Indicators is a medical device that received FDA 510(k) clearance on 2017-10-30. It is manufactured by Andersen Sterilizers, Inc.. The 510(k) number is K170426.

When was AN85/AN86 EO Indicators approved by the FDA?

AN85/AN86 EO Indicators received FDA 510(k) clearance on 2017-10-30, under approval number K170426.

What company makes AN85/AN86 EO Indicators?

AN85/AN86 EO Indicators is manufactured by Andersen Sterilizers, Inc..

What is the FDA product code for AN85/AN86 EO Indicators?

The FDA product code for AN85/AN86 EO Indicators is JOJ.

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Related Devices (Code: JOJ)

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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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