The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Card Guard, Model Cg-2000.
| Device ID | K882290 |
| 510k Number | K882290 |
| Device Name: | CARD GUARD, MODEL CG-2000 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 66/68 IBN. GVIROL ST. TEL AVIV 64952 Israel, IL |
| Contact | Dan Giora |
| Correspondent | Dan Giora CARD GUARD SCIENTIFIC SURVIVAL, LTD. 66/68 IBN. GVIROL ST. TEL AVIV 64952 Israel, IL |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-01 |
| Decision Date | 1988-07-22 |