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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 K131707
Device Name 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS
Applicant
3B MEDICAL, INC
21301 HWY 27 N
Lake Wales,  FL  33859
Applicant Contact ALEX LUCIO
Correspondent
3B MEDICAL, INC
21301 HWY 27 N
Lake Wales,  FL  33859
Correspondent Contact ALEX LUCIO
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/11/2013
Decision Date 08/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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