Decision Date2016-02-12
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
ProTrach Dualcare is the device name listed in this FDA 510(k) record. The listed applicant is Atos Medical AB. It received FDA 510(k) clearance on 2016-02-12 under 510(k) 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. The listed applicant is Atos Medical AB. The 510(k) number is K151404.
When did ProTrach Dualcare receive FDA 510(k) clearance?
ProTrach Dualcare received FDA 510(k) clearance on 2016-02-12, under 510(k) number K151404.
Who is the listed applicant for ProTrach Dualcare?
The FDA 510(k) record lists Atos Medical AB as the applicant. This does not by itself establish the device manufacturer.
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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