The following data is part of a premarket notification filed by Qingdao Hisense Medical Equipment Co.,ltd with the FDA for Hisense Ldc Monitor Models Hmd2g21/hmd3g21/hmd5g21.
| Device ID | K160347 |
| 510k Number | K160347 |
| Device Name: | Hisense LDC Monitor Models HMD2G21/HMD3G21/HMD5G21 |
| 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 | 2016-02-08 |
| Decision Date | 2016-03-03 |
| Summary: | summary |