SteadyTemp— 510(k) K233280

Substantially Equivalent

Steadysense GmbH

FDA 510(k) clearance K233280 for SteadyTemp, Substantially Equivalent on 2024-06-21. Applicant: Steadysense GmbH.

Clearance details

Applicant: Steadysense GmbH
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2023-09-29
Decision date: 2024-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seiersberg Pirka, AT

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.