Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503— 510(k) K193253
Substantially EquivalentShenzhen Changkun Technology Co., Ltd.
FDA 510(k) clearance K193253 for Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503, Substantially Equivalent on 2020-06-17. Applicant: Shenzhen Changkun Technology Co., Ltd..
Clearance details
- Applicant
- Shenzhen Changkun Technology Co., Ltd.
- Product code
- Code FLL
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Adverse events under product code FLL
product code FLL- Death
- 3
- Malfunction
- 557
- Total
- 560
Source: openFDA MAUDE database, through . 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.