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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K910521
Device Name SYSTEM 7300 PULSE OXIMETER
Applicant
ADVANCED MEDICAL INSTRUMENTS, INC.
3061 WEST ALBANY
BROKEN ARROW,  OK  74012
Applicant Contact JAMES LALICKER
Correspondent
ADVANCED MEDICAL INSTRUMENTS, INC.
3061 WEST ALBANY
BROKEN ARROW,  OK  74012
Correspondent Contact JAMES LALICKER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/07/1991
Decision Date 04/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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