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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 K132127
Device Name TRANSCEND AUTO
Applicant
SOMNETICS INTERNATIONAL, INC.
33 5TH AVE NW, STE 500
NEW BRIGHTON,  MN  55112
Applicant Contact MELINDA SWANSON
Correspondent
SOMNETICS INTERNATIONAL, INC.
33 5TH AVE NW, STE 500
NEW BRIGHTON,  MN  55112
Correspondent Contact MELINDA SWANSON
Regulation Number868.5905
Classification Product Code
BZD  
Date Received07/10/2013
Decision Date 10/17/2013
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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