The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Cg-6108 Arrhythmia Ecg Event Recorder.
| Device ID | K060911 |
| 510k Number | K060911 |
| Device Name: | CG-6108 ARRHYTHMIA ECG EVENT RECORDER |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-03 |
| Decision Date | 2006-08-22 |
| Summary: | summary |