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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 K984570
Device Name MINOLTA PULSOX-3/MINOLTA PULSOX-3I
Applicant
IN-X CORP.
1610 PIERCE STREET, SUITE 150
LAKEWOOD,  CO  80214 -1489
Applicant Contact CHARLIE HENRY
Correspondent
IN-X CORP.
1610 PIERCE STREET, SUITE 150
LAKEWOOD,  CO  80214 -1489
Correspondent Contact CHARLIE HENRY
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/23/1998
Decision Date 08/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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