AIRSEP NEWLIFE AIR OUTLET OPTION

Nebulizer (direct Patient Interface)

AIRSEP CORP.

The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Airsep Newlife Air Outlet Option.

Pre-market Notification Details

Device IDK944020
510k NumberK944020
Device Name:AIRSEP NEWLIFE AIR OUTLET OPTION
ClassificationNebulizer (direct Patient Interface)
Applicant AIRSEP CORP. 290 CREEKSIDE DR. Buffalo,  NY  14228
ContactEdward E Vrana
CorrespondentEdward E Vrana
AIRSEP CORP. 290 CREEKSIDE DR. Buffalo,  NY  14228
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-16
Decision Date1995-03-16

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