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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 K132516
Device Name OXIPROBE E (OXIPROBE)
Applicant
BIO MEDICAL TECHNOLOGIES CO., LTD
P.O. BOX 560
STILLWATER,  MN  55082
Applicant Contact ELAINE DUNCAN
Correspondent
BIO MEDICAL TECHNOLOGIES CO., LTD
P.O. BOX 560
STILLWATER,  MN  55082
Correspondent Contact ELAINE DUNCAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/12/2013
Decision Date 07/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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