RESPICHAMBER VALVED HOLDING CHAMBER

Holding Chambers, Direct Patient Interface

TRUDELL MEDICAL INTL.

The following data is part of a premarket notification filed by Trudell Medical Intl. with the FDA for Respichamber Valved Holding Chamber.

Pre-market Notification Details

Device IDK110136
510k NumberK110136
Device Name:RESPICHAMBER VALVED HOLDING CHAMBER
ClassificationHolding Chambers, Direct Patient Interface
Applicant TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario,  CA N5v 5g4
ContactDarryl Fisher
CorrespondentDarryl Fisher
TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario,  CA N5v 5g4
Product CodeNVP  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-18
Decision Date2011-04-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10762860001135 K110136 000

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