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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K850794
Device Name PATIENT MONITOR MODEL RM-300
Applicant
HONEYWELL, INC.
ONE CAMPUS DR.
PLEASANTVILLE,  NY  10570
Applicant Contact MARTIN KUTIK
Correspondent
HONEYWELL, INC.
ONE CAMPUS DR.
PLEASANTVILLE,  NY  10570
Correspondent Contact MARTIN KUTIK
Regulation Number870.4240
Classification Product Code
DTR  
Date Received02/26/1985
Decision Date 04/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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