SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405)— 510(k) K062784
Substantially EquivalentSejoy Electronics & Instruments Co., Ltd.
FDA 510(k) clearance K062784 for SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405), Substantially Equivalent on 2007-05-04. Applicant: Sejoy Electronics & Instruments Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Sejoy Electronics & Instruments 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
- Abbreviated
- Location
- Stoughton, MA, US
Recent devices under product code FLL
view all- K253162 — Temperature probes (5 models)
- K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
- K250470 — Ear Thermometer (3 models)
- K243000 — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
More clearances from Sejoy Electronics & Instruments Co., Ltd.
view all- K161577 — Arm-Type Fully Automatic Digital Blood Pressure Monitor
- K153149 — 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
- K153146 — Infrared Ear Thermometer
- K152426 — Wrist - Type Fully Automatic Digital Blood Pressure Monitor
- K152687 — Arm-Type Fully Automatic Digital Blood Pressure Monitor
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.