RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES— 510(k) K030324
Substantially EquivalentRadiant Innovation, Inc.
FDA 510(k) clearance K030324 for RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES, Substantially Equivalent on 2003-02-27. Applicant: Radiant Innovation, Inc.. Device class: 2.
Clearance details
- Applicant
- Radiant Innovation, 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
- Special
- Location
- Hsinchu City, TW
Recent devices under product code FLL
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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 Radiant Innovation, 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.