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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 K820110
Device Name BIOX III
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 Received01/15/1982
Decision Date 02/12/1982
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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