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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, facility use
510(k) Number K190533
Device Name Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented
Applicant
Sleepnet Corporation
5 Merrill Industrial Drive
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 Number868.5895
Classification Product Code
CBK  
Date Received03/04/2019
Decision Date 07/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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