Temperature Probe— 510(k) K173194

Substantially Equivalent

Orantech, Inc.

FDA 510(k) clearance K173194 for Temperature Probe, Substantially Equivalent on 2018-10-10. Applicant: Orantech, Inc..

Clearance details

Applicant: Orantech, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2017-10-02
Decision date: 2018-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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.