The following data is part of a premarket notification filed by Nanjing Jusha Display Technology Co., Ltd with the FDA for Jusha-m550g/ Jusha-m550/m550g/m550 Lcd Monitor.
Device ID | K190848 |
510k Number | K190848 |
Device Name: | JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor |
Classification | Display, Diagnostic Radiology |
Applicant | Nanjing Jusha Display Technology Co., Ltd Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing, CN 210036 |
Contact | Zilong Liang |
Correspondent | Zilong Liang Nanjing Jusha Display Technology Co., Ltd Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing, CN 210036 |
Product Code | PGY |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-01 |
Decision Date | 2019-05-14 |
Summary: | summary |