Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241— 510(k) K210937
Substantially EquivalentAlicn Medical Shenzhen, Inc.
FDA 510(k) clearance K210937 for Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241, Substantially Equivalent on 2022-05-12. 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
- Shenzhen, CN
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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.