MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD

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 Mark 5 Nuvo 8 Ocsi, Mark 5 Nuvo 8 Std.

Pre-market Notification Details

Device IDK093308
510k NumberK093308
Device Name:MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD
ClassificationGenerator, Oxygen, Portable
Applicant NIDEK MEDICAL PRODUCTS, INC. 3949 VALLEY EAST INDUSTRIAL DR Birmingham,  AL  35217
ContactJennifer Mcwilliams
CorrespondentJennifer Mcwilliams
NIDEK MEDICAL PRODUCTS, INC. 3949 VALLEY EAST INDUSTRIAL DR Birmingham,  AL  35217
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-22
Decision Date2010-01-14

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