The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Cg-900p Fetal/maternal Monitor.
| Device ID | K010552 |
| 510k Number | K010552 |
| Device Name: | CG-900P FETAL/MATERNAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. Rehovot, IL 76100 |
| Contact | Leonid Trachtenberg |
| Correspondent | Leonid Trachtenberg CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. Rehovot, IL 76100 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-26 |
| Decision Date | 2001-05-11 |