The following data is part of a premarket notification filed by Card Guard Ltd. with the FDA for Model Cg-2206 Personal Electrocardiogram (ecg) Transmitter Device (modified).
| Device ID | K963725 |
| 510k Number | K963725 |
| Device Name: | MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED) |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARD GUARD LTD. 2 PEKERIS ST. Rehovot, IL 76100 |
| Contact | Alex Gonorovsky |
| Correspondent | Alex Gonorovsky CARD GUARD 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 | 1996-07-22 |
| Decision Date | 1997-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850725007057 | K963725 | 000 |