EAR THERMOMETER, MODEL WL-320X— 510(k) K042631
Substantially EquivalentInnovatech, Inc.
FDA 510(k) clearance K042631 for EAR THERMOMETER, MODEL WL-320X, Substantially Equivalent on 2004-12-22. Applicant: Innovatech, Inc.. Device class: 2.
Clearance details
- Applicant
- Innovatech, Inc.
- 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
- Pei Tun Dist. Taichung, TW
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- 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 Innovatech, Inc.
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.