EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65— 510(k) K042627
Substantially EquivalentMesure Technology Co., Ltd.
FDA 510(k) clearance K042627 for EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65, Substantially Equivalent on 2004-10-18. 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
- San Chung City, TW
Recent devices under product code FLL
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- K250470 — Ear Thermometer (3 models)
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- 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
- K071019 — DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES
- K063542 — WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F.
- K050303 — 5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X.
- 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.