Hailie Sensor NF0107 & NF0108— 510(k) K221994

Name: FDA 510(k) clearance K221994
Creator: U.S. Food and Drug Administration
Published: 2022-10-04

Substantially Equivalent

Adherium (Nz), Ltd.

FDA 510(k) clearance K221994 for Hailie Sensor NF0107 & NF0108, Substantially Equivalent on 2022-10-04. Applicant: Adherium (Nz), Ltd.. Device class: 2.

Clearance details

Applicant: Adherium (Nz), Ltd.
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 2022-07-06
Decision date: 2022-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

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More clearances from Adherium (Nz), Ltd.

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K222247 — Hailie Sensor NF01102023-02-08
K220622 — Hailie Sensor NF01062022-07-15
K211233 — Hailie Sensor NF01092021-08-18
K182638 — Hailie Sensor2019-06-19
K182573 — Hailie Sensor2019-06-07

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.