Hailie Sensor NF0107 & NF0108
K-Number: K221994 · 2022-10-04
ApplicantAdherium (Nz), Ltd.
Decision Date2022-10-04
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Hailie Sensor NF0107 & NF0108 is a medical device manufactured by Adherium (Nz), Ltd.. It received FDA 510(k) clearance on 2022-10-04 under approval number K221994. 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 NF0107 & NF0108?
Hailie Sensor NF0107 & NF0108 is a medical device that received FDA 510(k) clearance on 2022-10-04. It is manufactured by Adherium (Nz), Ltd.. The 510(k) number is K221994.
When was Hailie Sensor NF0107 & NF0108 approved by the FDA?
Hailie Sensor NF0107 & NF0108 received FDA 510(k) clearance on 2022-10-04, under approval number K221994.
What company makes Hailie Sensor NF0107 & NF0108?
Hailie Sensor NF0107 & NF0108 is manufactured by Adherium (Nz), Ltd..
What is the FDA product code for Hailie Sensor NF0107 & NF0108?
The FDA product code for Hailie Sensor NF0107 & NF0108 is CAF.
Other Devices by Adherium (Nz), Ltd.
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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.