Non-contact Infrared Thermometer— 510(k) K180207
Substantially EquivalentAlicn Medical (Shenzhen), Inc.
FDA 510(k) clearance K180207 for Non-contact Infrared Thermometer, Substantially Equivalent on 2018-11-28. Applicant: Alicn Medical (Shenzhen), Inc.. Device class: 2.
Clearance details
- Applicant
- Alicn Medical (Shenzhen), 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
- Shezhen, CN
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- 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 Alicn Medical (Shenzhen), Inc.
view all- K232338 — Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383
- K231050 — Arm Blood Pressure Monitor
- K230649 — Arm Blood Pressure Monitor
- K222248 — Infrared Thermometer
- K221913 — Arm Blood Pressure Monitor
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.