The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Card Guard, Model Cg-7100.
| Device ID | K964836 |
| 510k Number | K964836 |
| Device Name: | CARD GUARD, MODEL CG-7100 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 12 HACHOMA ST. Rishon Le-zion, IL 75655 |
| Contact | Leonid Trachtenberg |
| Correspondent | Leonid Trachtenberg CARD GUARD SCIENTIFIC SURVIVAL, LTD. 12 HACHOMA ST. Rishon Le-zion, IL 75655 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-29 |
| Decision Date | 1997-07-28 |