Hailie Sensor NF0109

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 Nf0109.

Pre-market Notification Details

Device IDK211233
510k NumberK211233
Device Name:Hailie Sensor NF0109
ClassificationNebulizer (direct Patient Interface)
Applicant Adherium (NZ) Ltd Level 11, 16 Kingston Street Auckland,  NZ 1010
ContactChris Mander
CorrespondentChris Mander
Adherium (NZ) Ltd Level 11, 16 Kingston Street Auckland,  NZ 1010
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-23
Decision Date2021-08-18

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