The following data is part of a premarket notification filed by Qingdao Hisense Medical Equipment Co., Ltd. with the FDA for Hisense 2mp/3mp Lcd Monitor (hmd2c21/hmd3c21).
| Device ID | K152030 |
| 510k Number | K152030 |
| Device Name: | Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) |
| Classification | Display, Diagnostic Radiology |
| Applicant | Qingdao Hisense Medical Equipment Co., Ltd. Software Outsourcing Center 3rd Floor North Wing No. 169 Songling Road, Laoshan Qing Dao, CN 266101 |
| Contact | Liu Zhitang |
| Correspondent | Liu Zhitang Qingdao Hisense Medical Equipment Co., Ltd. Software Outsourcing Center 3rd Floor North Wing No. 169 Songling Road, Laoshan Qing Dao, CN 266101 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-22 |
| Decision Date | 2015-09-16 |
| Summary: | summary |