The following data is part of a premarket notification filed by Mediana Co., Ltd. with the FDA for F10.
| Device ID | K110630 |
| 510k Number | K110630 |
| Device Name: | F10 |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | MEDIANA CO., LTD. 1650-1 DONGHWA-RI MUNMAK-CUP Wonju-city, Gangwon-do, KR 220-801 |
| Contact | Amy M.h. Kim |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-03-03 |
| Decision Date | 2011-06-24 |
| Summary: | summary |