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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Tracheostomy And Tube Cuff
510(k) Number K151404
Device Name ProTrach Dualcare
Applicant
Atos Medical AB
Kraftgatan 8
Horby,  SE SE-242 22
Applicant Contact Ferenc Dahner
Correspondent
Atos Medical AB
Kraftgatan 8
Horby,  SE SE-242 22
Correspondent Contact Ferenc Dahner
Regulation Number868.5800
Classification Product Code
JOH  
Date Received05/26/2015
Decision Date 02/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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