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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controls For Blood-Gases, (Assayed And Unassayed)
510(k) Number K152553
Device Name CueSee Hypoxic
Applicant
Eurotrol B.V.
Keplerlaan 20
Ede,  NL 6716 BS
Applicant Contact Paul Kooijmans
Correspondent
Eurotrol B.V.
Keplerlaan 20
Ede,  NL 6716 BS
Correspondent Contact Margherita La Marca
Regulation Number862.1660
Classification Product Code
JJS  
Date Received09/08/2015
Decision Date 04/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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