The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Card Guard, Model Cg-7000d Ecg Recorder/transmitter.
| Device ID | K942704 |
| 510k Number | K942704 |
| Device Name: | CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 19636 CLUB HOUSE RD., #120 Gaithersburg, MD 20879 |
| Contact | Daniel Gershoni |
| Correspondent | Daniel Gershoni CARD GUARD SCIENTIFIC SURVIVAL, LTD. 19636 CLUB HOUSE RD., #120 Gaithersburg, MD 20879 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-08 |
| Decision Date | 1994-12-05 |