The following data is part of a premarket notification filed by Bionet Co., Ltd. with the FDA for Fc 700 Fetal Monitor.
| Device ID | K043597 |
| 510k Number | K043597 |
| Device Name: | FC 700 FETAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | BIONET CO., LTD. MEDICAL INDUSTRY TECHNO TOWER R205, 1272 MAEJI HEUNGUP Wonju, Kwangwon-do, KR |
| Contact | Sun-young Jeong |
| Correspondent | Sun-young Jeong BIONET CO., LTD. MEDICAL INDUSTRY TECHNO TOWER R205, 1272 MAEJI HEUNGUP Wonju, Kwangwon-do, KR |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-29 |
| Decision Date | 2005-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18809276943597 | K043597 | 000 |