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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 K172335
Device Name Bleep DreamPort
Applicant
Snapcpap
143 Harrison Pond Dr.
Pittsboro,  NC  37312
Applicant Contact Stuart Heatherington
Correspondent
Snapcpap C/O Promedic, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/02/2017
Decision Date 03/30/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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