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FDA 510(k)

AN1036 Dosimeter

K-Number: K200334 · 2020-11-12

ApplicantAndersen Sterilizers, Inc.
Decision Date2020-11-12
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AN1036 Dosimeter 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 K200334. 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 AN1036 Dosimeter?

AN1036 Dosimeter 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 K200334.

When did AN1036 Dosimeter receive FDA 510(k) clearance?

AN1036 Dosimeter received FDA 510(k) clearance on 2020-11-12, under 510(k) number K200334.

Who is the listed applicant for AN1036 Dosimeter?

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 AN1036 Dosimeter?

The FDA product code for AN1036 Dosimeter 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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