Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60— 510(k) K202687
Substantially EquivalentShenzhen Lepu Intelligent Medical Equipment Co., Ltd.
FDA 510(k) clearance K202687 for Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60, Substantially Equivalent on 2021-02-18. Applicant: Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.
- Product code
- Code FLL
- Device class
- Class 2
- Regulation
- 21 CFR 880.2910
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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More clearances from Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.
view allAdverse 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.