The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Pmp4 Selfcheck Ecg.
| Device ID | K042254 |
| 510k Number | K042254 |
| Device Name: | PMP4 SELFCHECK ECG |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PERERIS ST., SCIENCE PARK Rehovot, IL 76100 |
| Contact | Naama Oren |
| Correspondent | Naama Oren CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PERERIS ST., SCIENCE PARK 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 | 2004-08-20 |
| Decision Date | 2005-01-13 |
| Summary: | summary |