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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 K960861
Device Name OMICRON MONITOR, DELTA MONITOR
Applicant
CORE-M, INC.
214 LINCOLN ST.
ALLSTON,  MA  02134
Applicant Contact C. LAWERENCE CHRISTMAN
Correspondent
CORE-M, INC.
214 LINCOLN ST.
ALLSTON,  MA  02134
Correspondent Contact C. LAWERENCE CHRISTMAN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/01/1996
Decision Date 08/19/1996
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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