CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER

Nebulizer (direct Patient Interface)

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 No. 1755 1s0-neb, A Filtered Nebulizer.

Pre-market Notification Details

Device IDK895231
510k NumberK895231
Device Name:CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
ClassificationNebulizer (direct Patient Interface)
Applicant HUDSON OXYGEN THERAPY SALES CO. 27711 DIAZ ST. P.O. BOX 66 Temecula,  CA  92390
ContactJorge Haider
CorrespondentJorge Haider
HUDSON OXYGEN THERAPY SALES CO. 27711 DIAZ ST. P.O. BOX 66 Temecula,  CA  92390
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-22
Decision Date1989-10-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
24026704645859 K895231 000
34026704642640 K895231 000
24026704661460 K895231 000
24026704670981 K895231 000
24026704670837 K895231 000
24026704595550 K895231 000
24026704390520 K895231 000

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