MONITORING EAR THERMOMETER, MODEL BTM-D1A— 510(k) K062445
Substantially EquivalentRio Flexon Technology Co., Ltd.
FDA 510(k) clearance K062445 for MONITORING EAR THERMOMETER, MODEL BTM-D1A, Substantially Equivalent on 2007-02-16. Applicant: Rio Flexon Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Rio Flexon Technology 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
- Jhonghe City Taipei County, TW
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More clearances from Rio Flexon Technology 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.