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FDA 510(k)

Hailie Sensor

K-Number: K181405 · 2018-12-10

ApplicantAdherium (Nz), Ltd.
Decision Date2018-12-10
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Hailie Sensor is a medical device manufactured by Adherium (Nz), Ltd.. It received FDA 510(k) clearance on 2018-12-10 under approval number K181405. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hailie Sensor?

Hailie Sensor is a medical device that received FDA 510(k) clearance on 2018-12-10. It is manufactured by Adherium (Nz), Ltd.. The 510(k) number is K181405.

When was Hailie Sensor approved by the FDA?

Hailie Sensor received FDA 510(k) clearance on 2018-12-10, under approval number K181405.

What company makes Hailie Sensor?

Hailie Sensor is manufactured by Adherium (Nz), Ltd..

What is the FDA product code for Hailie Sensor?

The FDA product code for Hailie Sensor is CAF.

Other Devices by Adherium (Nz), Ltd.

K163485SmartTouch K180407Smartinhaler K173310SmartTouch K182638Hailie Sensor K182573Hailie Sensor K211233Hailie Sensor NF0109

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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