AEROCHAMBER Z-STAT PLUS 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 Aerochamber Z-stat Plus Valved Holding Chamber.

Pre-market Notification Details

Device IDK052332
510k NumberK052332
Device Name:AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER
ClassificationHolding Chambers, Direct Patient Interface
Applicant TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario,  CA N5v 5g4
ContactJohn Straatman
CorrespondentJohn Straatman
TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario,  CA N5v 5g4
Product CodeNVP  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-26
Decision Date2005-09-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50604351887157 K052332 000
50604351787150 K052332 000
50604351797104 K052332 000
50604351797159 K052332 000
50604351797500 K052332 000
50604351797555 K052332 000
50604351807100 K052332 000
50604351807155 K052332 000
50604351887102 K052332 000
50604351787105 K052332 000

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