AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER

Nebulizer (direct Patient Interface)

TRUDELL MEDICAL INTL.

The following data is part of a premarket notification filed by Trudell Medical Intl. with the FDA for Aeroeclipse Durable Breath Actuated Nebulizer.

Pre-market Notification Details

Device IDK080926
510k NumberK080926
Device Name:AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER
ClassificationNebulizer (direct Patient Interface)
Applicant TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario,  CA N5v 5g4
ContactDarryl Fischer
CorrespondentDarryl Fischer
TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario,  CA N5v 5g4
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-02
Decision Date2008-08-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
62860105514020 K080926 000
62860105513047 K080926 000
62860105513016 K080926 000
62860105507022 K080926 000
00762860055131 K080926 000
00762860050303 K080926 000
62860105509026 K080926 000

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