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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K772056
Device Name PHYSIOLOGICAL MONITOR MODEL 871
Applicant
DATASCOPE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DATASCOPE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.2300
Classification Product Code
DRT  
Date Received10/31/1977
Decision Date 11/22/1977
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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