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FDA 510(k)

ProTrach Dualcare

K-Number: K151404 · 2016-02-12

ApplicantAtos Medical AB
Decision Date2016-02-12
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ProTrach Dualcare is a medical device manufactured by Atos Medical AB. It received FDA 510(k) clearance on 2016-02-12 under approval number K151404. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProTrach Dualcare?

ProTrach Dualcare is a medical device that received FDA 510(k) clearance on 2016-02-12. It is manufactured by Atos Medical AB. The 510(k) number is K151404.

When was ProTrach Dualcare approved by the FDA?

ProTrach Dualcare received FDA 510(k) clearance on 2016-02-12, under approval number K151404.

What company makes ProTrach Dualcare?

ProTrach Dualcare is manufactured by Atos Medical AB.

What is the FDA product code for ProTrach Dualcare?

The FDA product code for ProTrach Dualcare is JOH.

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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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