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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Blood-Pressure
510(k) Number K862647
Device Name PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403
Applicant
Ivy Biomedical Systems, Inc.
11 Business Park Dr.
Branford,  CT  06405
Applicant Contact RICHARD A MENTELOS
Correspondent
Ivy Biomedical Systems, Inc.
11 Business Park Dr.
Branford,  CT  06405
Correspondent Contact RICHARD A MENTELOS
Regulation Number870.1110
Classification Product Code
DSK  
Date Received07/11/1986
Decision Date 08/18/1986
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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