The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Cg-1000 Personal Ecg Transmitter.
| Device ID | K935909 |
| 510k Number | K935909 |
| Device Name: | CG-1000 PERSONAL ECG TRANSMITTER |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan 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 | 1993-12-09 |
| Decision Date | 1995-04-28 |