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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K123738
Device Name MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD
Applicant
NIDEK MEDICAL PRODUCTS, INC.
3949 VALLEY EAST INDUSTRIAL DR
BIRMINGHAM,  AL  35217
Applicant Contact VAN MUTH
Correspondent
NIDEK MEDICAL PRODUCTS, INC.
3949 VALLEY EAST INDUSTRIAL DR
BIRMINGHAM,  AL  35217
Correspondent Contact VAN MUTH
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/05/2012
Decision Date 02/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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