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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K983355
Device Name SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR
Applicant
Sabratek Corp.
11874 S. Evelyn Circle
Houston,  TX  77071 -3404
Applicant Contact J. HARVEY KNAUSS
Correspondent
Sabratek Corp.
11874 S. Evelyn Circle
Houston,  TX  77071 -3404
Correspondent Contact J. HARVEY KNAUSS
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/23/1998
Decision Date 03/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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