Qingdao Hisense Medical Equipment Co.,Ltd.
Qingdao Shandong, CN
Qingdao Hisense Medical Equipment Co.,Ltd. appears in FDA device records in Qingdao Shandong, CN. FDA records list 9 510(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 9 510(k) clearances for Qingdao Hisense Medical Equipment Co.,Ltd. between 2015 and 2024. The busiest year on record is 2022, with 4. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 2 |
| 2016 | 1 |
| 2022 | 4 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233841 | HD80 Series Ultrasound Diagnostic System | IYN | Substantially Equivalent | |
| K233439 | HD60 Series Ultrasound Diagnostic System | IYN | Substantially Equivalent | |
| K222208 | Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D | PGY | Substantially Equivalent | |
| K222132 | Hisense LCD monitor HMD2G21S, HMD3G21S | PGY | Substantially Equivalent | |
| K221567 | LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) | PGY | Substantially Equivalent | |
| K213862 | HD60 Series Ultrasound Diagnostic System | IYN | Substantially Equivalent | |
| K160347 | Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 | PGY | Substantially Equivalent | |
| K152030 | Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) | PGY | Substantially Equivalent | |
| K151709 | Hi-Light Diagnostic Ultrasound Systems | IYO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016696283 | 3016696283 | Qingdao Hisense Medical Equipment Co.,Ltd. | No. 399 Songling Road, Laoshan District, Qingdao Shandong 266100 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
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Data as of , FDA export datePage updated Source: openFDA, public domain