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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 K896788
Device Name DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF
Applicant
Advanced Medical Instruments, Inc.
3061 W. Albany
Broken Arrow,  OK  74012
Applicant Contact JAMES LALICKER
Correspondent
Advanced Medical Instruments, Inc.
3061 W. Albany
Broken Arrow,  OK  74012
Correspondent Contact JAMES LALICKER
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received12/04/1989
Decision Date 01/19/1990
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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