The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Card Guard Model Cg-8000.
| Device ID | K926515 |
| 510k Number | K926515 |
| Device Name: | CARD GUARD MODEL CG-8000 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 230 NORTH WASHINGTON ST. SUITE 400 Rockville, MD 20850 |
| Contact | Daniel Gershoni |
| Correspondent | Daniel Gershoni CARD GUARD SCIENTIFIC SURVIVAL, LTD. 230 NORTH WASHINGTON ST. SUITE 400 Rockville, MD 20850 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-30 |
| Decision Date | 1994-03-30 |