AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS

Nebulizer (direct Patient Interface)

Teleflex Medical, Inc.

The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Aquapak Nebulizer Adaptors/reservoirs.

Pre-market Notification Details

Device IDK141214
510k NumberK141214
Device Name:AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS
ClassificationNebulizer (direct Patient Interface)
Applicant Teleflex Medical, Inc. 2917 Weck Drive Research Triangle Park,  NC  27709
ContactJames A Cochie
CorrespondentJames A Cochie
Teleflex Medical, Inc. 2917 Weck Drive Research Triangle Park,  NC  27709
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-12
Decision Date2014-12-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
24026704612745 K141214 000
34026704627821 K141214 000
34026704627814 K141214 000
34026704627784 K141214 000
34026704627647 K141214 000
34026704627616 K141214 000
10197344007226 K141214 000
10197344007202 K141214 000
20197344006028 K141214 000
34026704627913 K141214 000
34026704627944 K141214 000
14026704611369 K141214 000
24026704597226 K141214 000
24026704597219 K141214 000
24026704597158 K141214 000
24026704597141 K141214 000
24026704597134 K141214 000
24026704597059 K141214 000
24026704597042 K141214 000
10197344007196 K141214 000

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