Alicn Medical Shenzhen, Inc
Shenzhen Guangdong, CN
ALICN MEDICAL SHENZHEN, INC appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Alicn Medical Shenzhen, Inc between 2018 and 2023. The busiest year on record is 2022, with 6. The most recent is 2023, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 6 |
| 2023 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | FLL | Substantially Equivalent | |
| K231050 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K230649 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K222248 | Infrared Thermometer | FLL | Substantially Equivalent | |
| K221913 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K210937 | Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 | FLL | Substantially Equivalent | |
| K210565 | Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 | FLL | Substantially Equivalent | |
| K212257 | Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 | FLL | Substantially Equivalent | |
| K212877 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K210564 | Infrared Thermometer | FLL | Substantially Equivalent | |
| K210563 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K180435 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K180207 | Non-contact Infrared Thermometer | FLL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009889471 | 3009889471 | ALICN MEDICAL SHENZHEN, INC | Room 301, Building D, Chaojie Industrial Park, No. 1 Guanghui Road, Shenzhen Guangdong 518122 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain
