Hailie Sensor NF0106

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 Nf0106.

Pre-market Notification Details

Device IDK220622
510k NumberK220622
Device Name:Hailie Sensor NF0106
ClassificationNebulizer (direct Patient Interface)
Applicant Adherium (NZ) Ltd Level 11, 16 Kingston Street Auckland,  NZ 1010
ContactGeoff Feakes
CorrespondentGeoff Feakes
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 Received2022-03-03
Decision Date2022-07-15

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