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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Adherium (Nz), Ltd.. It received FDA 510(k) clearance on 2022-10-04 under 510(k) 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. The listed applicant is Adherium (Nz), Ltd.. The 510(k) number is K221994.

When did Hailie Sensor NF0107 & NF0108 receive FDA 510(k) clearance?

Hailie Sensor NF0107 & NF0108 received FDA 510(k) clearance on 2022-10-04, under 510(k) number K221994.

Who is the listed applicant for Hailie Sensor NF0107 & NF0108?

The FDA 510(k) record lists Adherium (Nz), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hailie Sensor NF0107 & NF0108?

The FDA product code for Hailie Sensor NF0107 & NF0108 is CAF.

Other records listing Adherium (Nz), Ltd. as applicant

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Official Source

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

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