CATALOG 6400 OXYGEN CONCENTRATOR

Generator, Oxygen, Portable

HUDSON OXYGEN THERAPY SALES CO.

The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Catalog 6400 Oxygen Concentrator.

Pre-market Notification Details

Device IDK833938
510k NumberK833938
Device Name:CATALOG 6400 OXYGEN CONCENTRATOR
ClassificationGenerator, Oxygen, Portable
Applicant HUDSON OXYGEN THERAPY SALES CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-15
Decision Date1983-12-08

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