VORTEX VALVED HOLDING CHAMBER

Nebulizer (direct Patient Interface)

PARI INNOVATIVE MANUFACTURERS, INC.

The following data is part of a premarket notification filed by Pari Innovative Manufacturers, Inc. with the FDA for Vortex Valved Holding Chamber.

Pre-market Notification Details

Device IDK020944
510k NumberK020944
Device Name:VORTEX VALVED HOLDING CHAMBER
ClassificationNebulizer (direct Patient Interface)
Applicant PARI INNOVATIVE MANUFACTURERS, INC. 13800 HULL ST. RD. Midlothian,  VA  23112
ContactLawrence Weinstein
CorrespondentRobert Mosenkis
CITECH 5200 BUTLER PIKE Plymouth Meeting,  PA  19462 -1298
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2002-03-25
Decision Date2002-05-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00744229510444 K020944 000
00744229510536 K020944 000
00744229510543 K020944 000
00744229510512 K020944 000
00744229510598 K020944 000
00744229510017 K020944 000
00744229510055 K020944 000
00744229510291 K020944 000
00744229510307 K020944 000
00744229510338 K020944 000
00744229510369 K020944 000
00744229510383 K020944 000
00744229510406 K020944 000
00744229510420 K020944 000
00744229510529 K020944 000

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