CliniCloud Non-contact Thermometer, Model SPL1024— 510(k) K161325

Substantially Equivalent

Stethocloud Pty.Ltd (Clinicloud)

FDA 510(k) clearance K161325 for CliniCloud Non-contact Thermometer, Model SPL1024, Substantially Equivalent on 2016-06-22. Applicant: Stethocloud Pty.Ltd (Clinicloud).

Clearance details

Applicant: Stethocloud Pty.Ltd (Clinicloud)
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2016-05-12
Decision date: 2016-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne Vic, AU

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.