The following data is part of a premarket notification filed by Qingdao Hisense Medical Equipment Co., Ltd with the FDA for Hisense Lcd Monitor Hmd2c21a, Hmd4c27s, Hmd6c30d.
| Device ID | K222208 |
| 510k Number | K222208 |
| Device Name: | Hisense LCD Monitor HMD2C21A, HMD4C27S, HMD6C30D |
| Classification | Display, Diagnostic Radiology |
| Applicant | Qingdao Hisense Medical Equipment Co., Ltd No. 399 Songling Road, Laoshan District 266100, Qingdao, Shandong, P. R. China Qingdao, CN 266100 |
| Contact | Lu Zhonghao |
| Correspondent | Lu Zhonghao Qingdao Hisense Medical Equipment Co., Ltd No. 399 Songling Road, Laoshan District 266100, Qingdao, Shandong, P. R. China Qingdao, CN 266100 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-25 |
| Decision Date | 2022-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06933741405374 | K222208 | 000 |
| 06933741405350 | K222208 | 000 |
| 06933741405336 | K222208 | 000 |