The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Bp Pro Blood Pressure Monitor.
| Device ID | K053395 |
| 510k Number | K053395 |
| Device Name: | BP PRO BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. PO BOX 527 Rehovot, IL 76100 |
| Contact | Alex Gonorovsky |
| Correspondent | Alex Gonorovsky CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. PO BOX 527 Rehovot, IL 76100 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-06 |
| Decision Date | 2005-12-23 |
| Summary: | summary |