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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K860646
Device Name PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART
Applicant
Analogic Corp.
8 Centennial Dr.
Peabody,  MA  01960
Applicant Contact MARVIN ROSENBAUM
Correspondent
Analogic Corp.
8 Centennial Dr.
Peabody,  MA  01960
Correspondent Contact MARVIN ROSENBAUM
Regulation Number870.2340
Classification Product Code
DPS  
Date Received02/20/1986
Decision Date 10/16/1986
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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