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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K041376
Device Name C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A
Applicant
Analogic Corp.
8 Centennial Dr.
Peabody,  MA  01960
Applicant Contact DONALD J SHERRATT
Correspondent
Analogic Corp.
8 Centennial Dr.
Peabody,  MA  01960
Correspondent Contact DONALD J SHERRATT
Regulation Number870.2300
Classification Product Code
MWI  
Date Received05/24/2004
Decision Date 07/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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