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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
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