Aerobika OPEP Devive With Manometer

Spirometer, Therapeutic (incentive)

Trudell Medical International

The following data is part of a premarket notification filed by Trudell Medical International with the FDA for Aerobika Opep Devive With Manometer.

Pre-market Notification Details

Device IDK150173
510k NumberK150173
Device Name:Aerobika OPEP Devive With Manometer
ClassificationSpirometer, Therapeutic (incentive)
Applicant Trudell Medical International 725 Third Street London,ontario,  CA N5v 5g4
ContactDarryl Fischer
CorrespondentDarryl Fischer
Trudell Medical International 725 Third Street London,ontario,  CA N5v 5g4
Product CodeBWF  
CFR Regulation Number868.5690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-26
Decision Date2015-10-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
62860110504023 K150173 000
62860110502029 K150173 000
10762860105048 K150173 000
10762860105024 K150173 000

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