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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(With Arrhythmia Detection Or Alarms)
510(k) Number K980619
Device Name SABRATEK PATIENT HOME MANAGEMENT SYSTEM
Applicant
Sabratek Corp.
5601 W. Howard
Niles,  IL  60714
Applicant Contact EDWARD WADDELL
Correspondent
Sabratek Corp.
5601 W. Howard
Niles,  IL  60714
Correspondent Contact EDWARD WADDELL
Regulation Number870.1025
Classification Product Code
MHX  
Date Received02/18/1998
Decision Date 08/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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