The following data is part of a premarket notification filed by Kostec Co., Ltd with the FDA for Medical Lcd Monitor.
| Device ID | K141891 |
| 510k Number | K141891 |
| Device Name: | MEDICAL LCD MONITOR |
| Classification | Display, Diagnostic Radiology |
| Applicant | KOSTEC CO., LTD 2651 E. CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung KOSTEC CO., LTD 2651 E. CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-14 |
| Decision Date | 2014-08-04 |
| Summary: | summary |