The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Fetal Maternal Monitor Model F9 Express And Express.
| Device ID | K100797 |
| 510k Number | K100797 |
| Device Name: | FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS |
| Classification | System, Monitoring, Perinatal |
| Applicant | EDAN INSTRUMENTS, INC. 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Contact | Jigar Shah |
| Correspondent | Jigar Shah EDAN INSTRUMENTS, INC. 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-22 |
| Decision Date | 2010-11-10 |
| Summary: | summary |