The following data is part of a premarket notification filed by Mediana Co., Ltd. with the FDA for Fm20.
| Device ID | K110612 |
| 510k Number | K110612 |
| Device Name: | FM20 |
| Classification | System, Monitoring, Perinatal |
| Applicant | MEDIANA CO., LTD. WONJU MEDICAL IND. PARK 1650-1 DONGHWA-RI, MUNMAK-EUP Wonju-si, Gangwon-do, KR 220-801 |
| Contact | Amy Kim |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-03-03 |
| Decision Date | 2011-11-08 |
| Summary: | summary |