Celsi Monitor— 510(k) K230298

Substantially Equivalent

Hadleigh Health Technologies

FDA 510(k) clearance K230298 for Celsi Monitor, Substantially Equivalent on 2023-08-16. Applicant: Hadleigh Health Technologies.

Clearance details

Applicant: Hadleigh Health Technologies
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2023-02-02
Decision date: 2023-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Rafael, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.