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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 K864730
Device Name INVIVO PULSE OXIMETER, MODEL 4500
Applicant
INVIVO RESEARCH LABS, INC.
3061 W. ALBANY ST.
TULSA,  OK  74012
Applicant Contact ROGER SUSI
Correspondent
INVIVO RESEARCH LABS, INC.
3061 W. ALBANY ST.
TULSA,  OK  74012
Correspondent Contact ROGER SUSI
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/04/1986
Decision Date 05/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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