The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Card Guard Model Cg-6500.
| Device ID | K954350 |
| 510k Number | K954350 |
| Device Name: | CARD GUARD MODEL CG-6500 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 6156 EAST GREENWAY LN. Scottsdale, AZ 85254 |
| Contact | Boaz Vinogradov |
| Correspondent | Boaz Vinogradov CARD GUARD SCIENTIFIC SURVIVAL, LTD. 6156 EAST GREENWAY LN. Scottsdale, AZ 85254 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-18 |
| Decision Date | 1996-09-10 |