The following data is part of a premarket notification filed by Nanjing Jusha Display Technology Co., Ltd. with the FDA for C1210g Lcd Monitor, Jusha-c1210g Lcd Monitor, C1210 Lcd Monitor, Jusha-c1210 Lcd Monitor.
Device ID | K212231 |
510k Number | K212231 |
Device Name: | C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor |
Classification | Display, Diagnostic Radiology |
Applicant | Nanjing Jusha Display Technology Co., Ltd. 8A, Block 1. No. 301, Hanzhongmen Street Nanjing, CN 210036 |
Contact | Donny Lee |
Correspondent | Donny Lee Nanjing Jusha Display Technology Co., Ltd. 8A, Block 1. No. 301, Hanzhongmen 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 | 2021-07-16 |
Decision Date | 2022-03-25 |