INFRARED THERMOMETER— 510(k) K113761
Substantially EquivalentFamidoc Technology Co., Ltd.
FDA 510(k) clearance K113761 for INFRARED THERMOMETER, Substantially Equivalent on 2012-09-07. Applicant: Famidoc Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Famidoc 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
- Traditional
- Location
- Shenzhen, CN
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 Famidoc Technology Co., Ltd.
view all- K212918 — Heat StimPlus
- K130723 — FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL
- K113010 — FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
- K072641 — DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.
- K052849 — INFRARED THERMOMETER, FDIR-V1
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.