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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 K150365
Device Name Cloud9 System
Applicant
inSleep Technologies, LLC
12100 Singletree Lane Suite 183
Eden Prairie,  MN  55344
Applicant Contact Marty Kerber
Correspondent
EMERGO GROUP
816 CONGRESS AVENUE
SUITE 1400
AUSTIN,  TX  78701
Correspondent Contact Adrienne Lenz
Regulation Number868.5905
Classification Product Code
BZD  
Date Received02/12/2015
Decision Date 07/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT01949584
Reviewed by Third Party No
Combination Product No
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