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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 K192693
Device Name Nuvo Nano Portable Oxygen Concentrator
Applicant
Nidek Medical Products, Inc.
3949 Valley East Industrial Drive
Brimingham,  AL  35217
Applicant Contact Olivia Mullen
Correspondent
Nidek Medical Products, Inc.
3949 Valley East Industrial Drive
Brimingham,  AL  35217
Correspondent Contact Olivia Mullen
Regulation Number868.5440
Classification Product Code
CAW  
Date Received09/26/2019
Decision Date 05/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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