Nuvo Nano Portable Oxygen Concentrator

Generator, Oxygen, Portable

Nidek Medical Products, Inc.

The following data is part of a premarket notification filed by Nidek Medical Products, Inc. with the FDA for Nuvo Nano Portable Oxygen Concentrator.

Pre-market Notification Details

Device IDK192693
510k NumberK192693
Device Name:Nuvo Nano Portable Oxygen Concentrator
ClassificationGenerator, Oxygen, Portable
Applicant Nidek Medical Products, Inc. 3949 Valley East Industrial Drive Brimingham,  AL  35217
ContactOlivia Mullen
CorrespondentOlivia Mullen
Nidek Medical Products, Inc. 3949 Valley East Industrial Drive Brimingham,  AL  35217
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-26
Decision Date2020-05-07

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