The following data is part of a premarket notification filed by Kostec Co., Ltd with the FDA for Kostec Medical Grade Ldc Monitors.
| Device ID | K123944 |
| 510k Number | K123944 |
| Device Name: | KOSTEC MEDICAL GRADE LDC MONITORS |
| Classification | System, Image Processing, Radiological |
| Applicant | KOSTEC CO., LTD 144 RESEARCH DRIVE MEDICAL DEVICE DIVISION Hampton, VA 23666 |
| Contact | Rhonda Alexander, Ms, Mpa |
| Correspondent | Rhonda Alexander, Ms, Mpa KOSTEC CO., LTD 144 RESEARCH DRIVE MEDICAL DEVICE DIVISION Hampton, VA 23666 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-20 |
| Decision Date | 2013-09-05 |
| Summary: | summary |