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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 K833826
Device Name BTI BIOX III OXIMETER CRITICAL CAREUNI
Applicant
BIOX TECHNOLOGY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIOX TECHNOLOGY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/26/1983
Decision Date 12/30/1983
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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