The following data is part of a premarket notification filed by Mindchild Medical with the FDA for Mindchild Meridian M100 Fetal Heart Rate Monitor.
| Device ID | K142883 |
| 510k Number | K142883 |
| Device Name: | MindChild Meridian M100 Fetal Heart Rate Monitor |
| Classification | System, Monitoring, Perinatal |
| Applicant | Mindchild Medical 1600 Osgood Street #2-17 North Andover, MA 01845 |
| Contact | Jim Robertson |
| Correspondent | Leo Basta NorthStar Biomedical Associates 93 Benefit Street Providence, RI 02904 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-02 |
| Decision Date | 2015-04-17 |
| Summary: | summary |