The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Card Guard Personal Electrocardiogram Transmitter, Model Cg-6206/6306.
| Device ID | K000225 |
| 510k Number | K000225 |
| Device Name: | CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST., SCIENCE PARK P.O.B. 527 Rehovot, IL 76100 |
| Contact | Leonid Trachtenberg |
| Correspondent | Leonid Trachtenberg CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST., SCIENCE PARK P.O.B. 527 Rehovot, IL 76100 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-24 |
| Decision Date | 2000-02-11 |