SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL

Percussor, Powered-electric

ELECTROMED, INC.

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

Pre-market Notification Details

Device IDK053248
510k NumberK053248
Device Name:SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL
ClassificationPercussor, Powered-electric
Applicant ELECTROMED, INC. 103 EDGECUMBE DRIVE Mahtomedi,  MN  55115
ContactChet Sievert
CorrespondentNed Devine
INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough,  MA  01719
Product CodeBYI  
CFR Regulation Number868.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-11-21
Decision Date2005-12-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B102070716S0100 K053248 000
B102070124S3440 K053248 000
B102070124S1580 K053248 000
B102070124S1240 K053248 000
B102070124S0320 K053248 000
B102070107S0200 K053248 000
B102070107S0100 K053248 000
B102070094S1110 K053248 000
B102070094S1100 K053248 000
B102070094S0110 K053248 000
B102070124S3920 K053248 000
B102070124S4100 K053248 000
B102070686S0100 K053248 000
B102070622S0100 K053248 000
B102070137S8400 K053248 000
B102070137S1240 K053248 000
B102070124S9990 K053248 000
B102070124S8400 K053248 000
B102070124S7920 K053248 000
B102070124S7840 K053248 000
B102070124S4840 K053248 000
B102070094S0100 K053248 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.