GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000— 510(k) K060649
Substantially EquivalentTyco Healthcare Group LP
FDA 510(k) clearance K060649 for GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000, Substantially Equivalent on 2006-05-22. Applicant: Tyco Healthcare Group LP. Device class: 2.
Clearance details
- Applicant
- Tyco Healthcare Group LP
- 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
- Mansfield, 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 Tyco Healthcare Group LP
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 →
Recalls naming K060649
K-number listed on FDA's recall record- Z-0990-2020 — Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000
- Z-0991-2020 — Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
- Z-0992-2020 — Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062
- Z-0993-2020 — Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063
- Z-0994-2020 — Genius 2 Tympanic Thermometer Private Label Item Code: 3069
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060649.
Data sourced from openFDA. This site is unofficial and independent of the FDA.