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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 K133090
Device Name OXICARE FINGERTIP PULSE OXIMETER
Applicant
Delbio Incorporation
4405 Cushing Pkwy.
Fremont City,  CA  94538
Applicant Contact ERICA LI
Correspondent
Delbio Incorporation
4405 Cushing Pkwy.
Fremont City,  CA  94538
Correspondent Contact ERICA LI
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/30/2013
Decision Date 02/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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