AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE

Spirometer, Therapeutic (incentive)

TRUDELL MEDICAL INTL.

The following data is part of a premarket notification filed by Trudell Medical Intl. with the FDA for Aerobika Positive Expiratory Pressure Device.

Pre-market Notification Details

Device IDK123400
510k NumberK123400
Device Name:AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
ClassificationSpirometer, Therapeutic (incentive)
Applicant TRUDELL MEDICAL INTL. 725 THIRD ST. London,  CA N5v 5g4
ContactDarryl Fischer
CorrespondentDarryl Fischer
TRUDELL MEDICAL INTL. 725 THIRD ST. London,  CA N5v 5g4
Product CodeBWF  
CFR Regulation Number868.5690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-05
Decision Date2013-05-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
62860110501046 K123400 000
62860110501022 K123400 000
00762860105010 K123400 000

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