The following data is part of a premarket notification filed by Mindchild Medical with the FDA for Mindchild Meridian Fetal Heart Rate Monitor.
| Device ID | K120018 |
| 510k Number | K120018 |
| Device Name: | MINDCHILD MERIDIAN FETAL HEART RATE MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | MINDCHILD MEDICAL 755 WESTMINSTER STREET UNIT 120 Providence, RI 02903 |
| Contact | Leo Basta |
| Correspondent | Leo Basta MINDCHILD MEDICAL 755 WESTMINSTER STREET UNIT 120 Providence, RI 02903 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-03 |
| Decision Date | 2012-09-19 |
| Summary: | summary |