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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 K092549
Device Name OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P
Applicant
BIO MEDICAL TECHNOLOGIES CO., LTD
5536 TROWBRIDGE DRIVE
DUNWOODY,  GA  30338
Applicant Contact CATHRYN CAMBRIA
Correspondent
BIO MEDICAL TECHNOLOGIES CO., LTD
5536 TROWBRIDGE DRIVE
DUNWOODY,  GA  30338
Correspondent Contact CATHRYN CAMBRIA
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/19/2009
Decision Date 11/16/2009
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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