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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
Predetermined Change
Control Plan Authorized		 No
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