The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Pacemaker Data Pmd Transmitter, Model Cg-4000.
| Device ID | K983026 |
| 510k Number | K983026 |
| Device Name: | PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| 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 | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-31 |
| Decision Date | 1998-12-02 |