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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 K160127
Device Name iCodeConnect
Applicant
3B MEDICAL, INC.
799 Overlook Drive
winter haven,  FL  33884
Applicant Contact alex lucio
Correspondent
3B MEDICAL, INC.
799 Overlook Drive
winter haven,  FL  33884
Correspondent Contact alex lucio
Regulation Number868.5905
Classification Product Code
BZD  
Date Received01/20/2016
Decision Date 11/10/2016
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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