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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, diagnostic, pre-programmed, single-function
510(k) Number K863308
Device Name 2200I PHYSIOLOGICAL MONITOR
Applicant
DATASCOPE CORP.
580 WINTERS AVE.
P.O. BOX 5
PARAMUS,  NJ  07653
Applicant Contact ARTHUR FRIEDMAN
Correspondent
DATASCOPE CORP.
580 WINTERS AVE.
P.O. BOX 5
PARAMUS,  NJ  07653
Correspondent Contact ARTHUR FRIEDMAN
Regulation Number870.1435
Classification Product Code
DXG  
Date Received08/25/1986
Decision Date 01/02/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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