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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 K100815
Device Name OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316
Applicant
Oxypulse
One Macdonal Center
1 N. Macdonald Suite #8
Mesa,  AZ  85201
Applicant Contact JAMES A DUNNING
Correspondent
Oxypulse
One Macdonal Center
1 N. Macdonald Suite #8
Mesa,  AZ  85201
Correspondent Contact JAMES A DUNNING
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/23/2010
Decision Date 06/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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