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FDA 510(k)

SteriTrak

K-Number: K203605 · 2021-04-23

ApplicantArbutus Medical, Inc.
Decision Date2021-04-23
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SteriTrak is a medical device manufactured by Arbutus Medical, Inc.. It received FDA 510(k) clearance on 2021-04-23 under approval number K203605. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SteriTrak?

SteriTrak is a medical device that received FDA 510(k) clearance on 2021-04-23. It is manufactured by Arbutus Medical, Inc.. The 510(k) number is K203605.

When was SteriTrak approved by the FDA?

SteriTrak received FDA 510(k) clearance on 2021-04-23, under approval number K203605.

What company makes SteriTrak?

SteriTrak is manufactured by Arbutus Medical, Inc..

What is the FDA product code for SteriTrak?

The FDA product code for SteriTrak is JEC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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