Hailie Sensor

Nebulizer (direct Patient Interface)

Adherium (NZ) Ltd

The following data is part of a premarket notification filed by Adherium (nz) Ltd with the FDA for Hailie Sensor.

Pre-market Notification Details

Device IDK182638
510k NumberK182638
Device Name:Hailie Sensor
ClassificationNebulizer (direct Patient Interface)
Applicant Adherium (NZ) Ltd Level 2, 204 Quay Street Auckland,  NZ 1010
ContactChris Mander
CorrespondentChris Mander
Adherium (NZ) Ltd Level 2, 204 Quay Street Auckland,  NZ 1010
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-24
Decision Date2019-06-19

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