Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36— 510(k) K153149
Substantially EquivalentSejoy Electronics & Instruments Co., Ltd.
FDA 510(k) clearance K153149 for Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36, Substantially Equivalent on 2016-05-27. Applicant: Sejoy Electronics & Instruments Co., Ltd..
Clearance details
- Applicant
- Sejoy Electronics & Instruments Co., Ltd.
- Product code
- Code FLL
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hang Zhou, 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.