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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 K162014
Device Name Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)
Applicant
Bluepoint Medical GmbH & Co. KG
An Der Trave 15
Selmsdorf,  DE 23923
Applicant Contact BERND LINDNER
Correspondent
Imagenix, Inc.
S65w35739 Piper Rd.
Egale,  WI  53119
Correspondent Contact STEPHEN GORSKI
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/21/2016
Decision Date 02/06/2017
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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