The following data is part of a premarket notification filed by Qingdao Hisense Medical Equipment Co., Ltd. with the FDA for Lcd Monitor (hmd3c21s), Lcd Monitor (hmd5g21s).
| Device ID | K221567 |
| 510k Number | K221567 |
| Device Name: | LCD Monitor (HMD3C21S), LCD Monitor (HMD5G21S) |
| Classification | Display, Diagnostic Radiology |
| Applicant | Qingdao Hisense Medical Equipment Co., Ltd. No. 399 Songling Road, Laoshan District Qingdao, CN 266100 |
| Contact | Li Mingcheng |
| Correspondent | Hanson Chen Shenzhen Joyantech Consulting Co., Ltd 1713A,17th Floor,Block A, Zhongguan Times Square, Nanshan District, Shenzhen Shenzhen, CN GD755 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-31 |
| Decision Date | 2022-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06933741405244 | K221567 | 000 |
| 06933741405237 | K221567 | 000 |