Hailie Sensor NF0109
K-Number: K211233 · 2021-08-18
ApplicantAdherium (Nz), Ltd.
Decision Date2021-08-18
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Hailie Sensor NF0109 is a medical device manufactured by Adherium (Nz), Ltd.. It received FDA 510(k) clearance on 2021-08-18 under approval number K211233. 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 NF0109?
Hailie Sensor NF0109 is a medical device that received FDA 510(k) clearance on 2021-08-18. It is manufactured by Adherium (Nz), Ltd.. The 510(k) number is K211233.
When was Hailie Sensor NF0109 approved by the FDA?
Hailie Sensor NF0109 received FDA 510(k) clearance on 2021-08-18, under approval number K211233.
What company makes Hailie Sensor NF0109?
Hailie Sensor NF0109 is manufactured by Adherium (Nz), Ltd..
What is the FDA product code for Hailie Sensor NF0109?
The FDA product code for Hailie Sensor NF0109 is CAF.
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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.