Electro Flo 6 Airway Clearance System

Percussor, Powered-electric

Med Systems, Inc.

The following data is part of a premarket notification filed by Med Systems, Inc. with the FDA for Electro Flo 6 Airway Clearance System.

Pre-market Notification Details

Device IDK201490
510k NumberK201490
Device Name:Electro Flo 6 Airway Clearance System
ClassificationPercussor, Powered-electric
Applicant Med Systems, Inc. 2631 Ariane Drive San Diego,  CA  92117
ContactSusan B Davis
CorrespondentFrederick Cahn
BioMedical Strategies 133 Colonial Dr. White River Junction,  VT  05001
Product CodeBYI  
CFR Regulation Number868.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-04
Decision Date2021-02-12

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