The following data is part of a premarket notification filed by Nanjing Jusha Display Technology Co., Ltd with the FDA for Jusha-m52c Medical Display.
Device ID | K150746 |
510k Number | K150746 |
Device Name: | JUSHA-M52C Medical Display |
Classification | Display, Diagnostic Radiology |
Applicant | NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD 301 HNAZHONGMEN STREET, 8F, NO. 1 NANJING INTERNATIONAL SERVICE OUTSOURCING Mansion, Nanjing, CN 210036 |
Contact | Ma Jing |
Correspondent | Ma Jing NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD 301 HNAZHONGMEN STREET, 8F, NO. 1 NANJING INTERNATIONAL SERVICE OUTSOURCING Mansion, 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 | 2015-03-23 |
Decision Date | 2015-04-14 |
Summary: | summary |