Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618— 510(k) K212346

Substantially Equivalent

Shenzhen Pango Medical Electronics Co., Ltd.

FDA 510(k) clearance K212346 for Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618, Substantially Equivalent on 2022-05-05. Applicant: Shenzhen Pango Medical Electronics Co., Ltd..

Clearance details

Applicant: Shenzhen Pango Medical Electronics Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2021-07-28
Decision date: 2022-05-05
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.