The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Us Sensor #cg-930p; Toco Sensor Cg-940p.
| Device ID | K003876 |
| 510k Number | K003876 |
| Device Name: | US SENSOR #CG-930P; TOCO SENSOR CG-940P |
| Classification | Monitor, Heart Rate, Fetal, Ultrasonic |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. Rehovot, IL 76100 |
| Contact | Alex Gonorovsky |
| Correspondent | Alex Gonorovsky CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. Rehovot, IL 76100 |
| Product Code | HEL |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-15 |
| Decision Date | 2001-07-09 |