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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 K190254
Device Name Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
Applicant
Sleepnet Corporation
5 Merrill Industrial Dr.
Hampton,  NH  03842
Applicant Contact Jennifer Kennedy
Correspondent
Sleepnet Corporation % Promedic, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5905
Classification Product Code
BZD  
Date Received02/07/2019
Decision Date 07/05/2019
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
Recalls CDRH Recalls
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