Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AN1036 Dosimeter

K-Number: K200334 · 2020-11-12

Decision Date2020-11-12
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AN1036 Dosimeter is a medical device manufactured by Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2020-11-12 under approval 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. It is manufactured by Andersen Sterilizers, Inc.. The 510(k) number is K200334.

When was AN1036 Dosimeter approved by the FDA?

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

What company makes AN1036 Dosimeter?

AN1036 Dosimeter is manufactured by Andersen Sterilizers, Inc..

What is the FDA product code for AN1036 Dosimeter?

The FDA product code for AN1036 Dosimeter is JOJ.

Other Devices by Andersen Sterilizers, Inc.

View all 13 devices →

Related Devices (Code: JOJ)

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.