Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K190831 |
Device Name |
E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor |
Applicant |
Nanjing Jusha Display Technology Co., Ltd |
Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. |
Nanjing,
CN
210036
|
|
Applicant Contact |
Zilong Liang |
Correspondent |
Nanjing Jusha Display Technology Co., Ltd |
Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. |
Nanjing,
CN
210036
|
|
Correspondent Contact |
Zilong Liang |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/01/2019 |
Decision Date | 05/31/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|