The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Cg-2211 Selfcheck Ecg Transmitter.
| Device ID | K012223 |
| 510k Number | K012223 |
| Device Name: | CG-2211 SELFCHECK ECG TRANSMITTER |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. Rehovot, IL 76100 |
| Contact | Alex Gonorovsky |
| Correspondent | Alex Gonorovsky CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. Rehovot, IL 76100 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2001-09-10 |
| Summary: | summary |