DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES— 510(k) K071019
Substantially EquivalentMesure Technology Co., Ltd.
FDA 510(k) clearance K071019 for DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES, Substantially Equivalent on 2007-04-27. Applicant: Mesure Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Mesure 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
- Special
- Location
- Taipei Hsien, TW
Recent devices under product code FLL
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- 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 Mesure Technology Co., Ltd.
view all- K080981 — EAR THERMOMETER, MODELS ST66 AND ST67
- K063542 — WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F.
- K050303 — 5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X.
- K042627 — EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65
- K042013 — DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F
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.