Hailie Sensor NF0106— 510(k) K220622

Substantially Equivalent

Adherium (Nz), Ltd.

FDA 510(k) clearance K220622 for Hailie Sensor NF0106, Substantially Equivalent on 2022-07-15. Applicant: Adherium (Nz), Ltd..

Clearance details

Applicant: Adherium (Nz), Ltd.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2022-03-03
Decision date: 2022-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

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.