Electromed SmartVest Airway Clearance System

Percussor, Powered-electric

Electromed, Inc.

The following data is part of a premarket notification filed by Electromed, Inc. with the FDA for Electromed Smartvest Airway Clearance System.

Pre-market Notification Details

Device IDK222496
510k NumberK222496
Device Name:Electromed SmartVest Airway Clearance System
ClassificationPercussor, Powered-electric
Applicant Electromed, Inc. 500 Sixth Ave NW New Prague,  MN  56071
ContactGregory Spurlock
CorrespondentGregory Spurlock
Electromed, Inc. 500 Sixth Ave NW New Prague,  MN  56071
Product CodeBYI  
CFR Regulation Number868.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-18
Decision Date2022-11-18

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.