The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Card Guard, Model Cg-9000.
| Device ID | K924486 |
| 510k Number | K924486 |
| Device Name: | CARD GUARD, MODEL CG-9000 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 -1109 |
| Contact | Johnathan S Kahan |
| Correspondent | Johnathan S Kahan CARD GUARD SCIENTIFIC SURVIVAL, LTD. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 -1109 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-03 |
| Decision Date | 1994-10-31 |