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FDA 510(k)

Hailie Sensor NF0110

K-Number: K222247 · 2023-02-08

Decision Date2023-02-08
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Hailie Sensor NF0110 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 2023-02-08 under 510(k) number K222247. 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 NF0110?

Hailie Sensor NF0110 is a medical device that received FDA 510(k) clearance on 2023-02-08. The listed applicant is Adherium (Nz), Ltd.. The 510(k) number is K222247.

When did Hailie Sensor NF0110 receive FDA 510(k) clearance?

Hailie Sensor NF0110 received FDA 510(k) clearance on 2023-02-08, under 510(k) number K222247.

Who is the listed applicant for Hailie Sensor NF0110?

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 NF0110?

The FDA product code for Hailie Sensor NF0110 is CAF.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: CAF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.