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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K180388
Device Name Transcend 365 miniCPAP System
Applicant
Somnetics International, Inc.
33 5th Ave NW, Suite 500
New Brighton,  MN  55112
Applicant Contact Eric Becker
Correspondent
Bluebird Consulting, LLC
100 NE 2nd St. #340
Minneapolis,  MN  55413
Correspondent Contact Melinda Swanson
Regulation Number868.5905
Classification Product Code
BZD  
Subsequent Product Code
BTT  
Date Received02/13/2018
Decision Date 11/30/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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