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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K031128
FOIA Releasable 510(k) K031128
Device Name B-SMART, MODEL B-01
Applicant
MACOSTA MEDICAL USA, LLC
5 WHITCOMB AVENUE
AYER,  MA  01432
Applicant Contact PAMELA PAPINEAU
Correspondent
MACOSTA MEDICAL USA, LLC
5 WHITCOMB AVENUE
AYER,  MA  01432
Correspondent Contact PAMELA PAPINEAU
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received04/09/2003
Decision Date 01/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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