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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K022482
Device Name SENSA-CUFF, MODELS INFANT, CHILD, ADULT
Applicant
Ge Medical Systems Information Technologies
4502 Woodland Corporate Blvd.
Tampa,  FL  33614
Applicant Contact MELISSA ROBINSON
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received07/29/2002
Decision Date 08/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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