AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002

Apparatus, Nitric Oxide Delivery

PULMONOX MEDICAL CORP.

The following data is part of a premarket notification filed by Pulmonox Medical Corp. with the FDA for Aeronox Universal, Model P/n 360000, Aeronox Bedside, Model P/n 360001, Aeronox Transport Transport, Model P/n 360002.

Pre-market Notification Details

Device IDK000653
510k NumberK000653
Device Name:AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002
ClassificationApparatus, Nitric Oxide Delivery
Applicant PULMONOX MEDICAL CORP. 5243-53 AVE. Tofield, Alberta,  CA T0b 4j0
ContactPaula Tomat
CorrespondentPaula Tomat
PULMONOX MEDICAL CORP. 5243-53 AVE. Tofield, Alberta,  CA T0b 4j0
Product CodeMRN  
Subsequent Product CodeMRO
Subsequent Product CodeMRP
Subsequent Product CodeMRQ
CFR Regulation Number868.5165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-28
Decision Date2000-08-04

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