The following data is part of a premarket notification filed by Nanjing Jusha Display Technology Co., Ltd with the FDA for Jusha-c33c Lcd Monitor.
Device ID | K141684 |
510k Number | K141684 |
Device Name: | JUSHA-C33C LCD MONITOR |
Classification | Display, Diagnostic Radiology |
Applicant | NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD 8A, BLOCK 1 NANJING INTERNATIONAL SERVICE OUTSOURCING MANSION, NO. 301 Hauzhongmen Street, Nanjing, CN 210036 |
Contact | Li Le |
Correspondent | Li Le NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD 8A, BLOCK 1 NANJING INTERNATIONAL SERVICE OUTSOURCING MANSION, NO. 301 Hauzhongmen Street, 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 | 2014-06-23 |
Decision Date | 2014-08-01 |
Summary: | summary |