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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 the device name listed in this FDA 510(k) record. The listed applicant is Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2017-10-30 under 510(k) 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. The listed applicant is Andersen Sterilizers, Inc.. The 510(k) number is K170426.

When did AN85/AN86 EO Indicators receive FDA 510(k) clearance?

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

Who is the listed applicant for AN85/AN86 EO Indicators?

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 AN85/AN86 EO Indicators?

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

Other records listing Andersen Sterilizers, Inc. as applicant

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Related Devices (Code: JOJ)

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.

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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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