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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 K173973
Device Name TV-100
Applicant
Bio-Med Devices, Inc.
61 Soundview Road
Guilford,  CT  06437
Applicant Contact Ken Close
Correspondent
Bio-Med Devices c/o ProMedic, LLC
61 Soundview Road
Guilford,  CT  06437
Correspondent Contact Paul Dryden
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/29/2017
Decision Date 07/20/2018
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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