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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 K060616
Device Name NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100
Applicant
PHD Medical
4 Innovation Dr.
Dundas,  CA L9H 7P3
Applicant Contact NANCY RUTH
Correspondent
PHD Medical
4 Innovation Dr.
Dundas,  CA L9H 7P3
Correspondent Contact NANCY RUTH
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/08/2006
Decision Date 06/29/2006
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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