AeroDVx System

Sleeve, Limb, Compressible

Sun Scientific Inc

The following data is part of a premarket notification filed by Sun Scientific Inc with the FDA for Aerodvx System.

Pre-market Notification Details

Device IDK183349
510k NumberK183349
Device Name:AeroDVx System
ClassificationSleeve, Limb, Compressible
Applicant Sun Scientific Inc 145 Palisade Street Dobbs Ferry,  NY  10522
ContactAllan Alward
CorrespondentAllan Alward
Sun Scientific Inc 145 Palisade Street Dobbs Ferry,  NY  10522
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-03
Decision Date2019-07-19

NIH GUDID Devices

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