MYSTIQUE ULTRASONIC NEBULIZER

Nebulizer (direct Patient Interface)

AIRSEP CORP.

The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Mystique Ultrasonic Nebulizer.

Pre-market Notification Details

Device IDK983002
510k NumberK983002
Device Name:MYSTIQUE ULTRASONIC NEBULIZER
ClassificationNebulizer (direct Patient Interface)
Applicant AIRSEP CORP. 290 CREEKSIDE DR. Buffalo,  NY  14228
ContactEdward Vrana
CorrespondentEdward 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 Received1998-08-28
Decision Date1998-10-16

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