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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 K881939
Device Name SIRECUST 1280/1281 & 960/961 PATIENT MONITORS
Applicant
Siemens Medical Electronics
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact ROBERT R MURFITT
Correspondent
Siemens Medical Electronics
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact ROBERT R MURFITT
Regulation Number870.2340
Classification Product Code
DPS  
Date Received05/09/1988
Decision Date 07/18/1988
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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