The following data is part of a premarket notification filed by Paieon, Inc. with the FDA for Cardiop-b System, Version 2.1.
| Device ID | K072591 |
| 510k Number | K072591 |
| Device Name: | CARDIOP-B SYSTEM, VERSION 2.1 |
| Classification | System, X-ray, Angiographic |
| Applicant | PAIEON, INC. 22 HAMELACHA ST., P.O.B. 11355 Rosh Haayin, IL 48901 |
| Contact | Ravit Barkama |
| Correspondent | Ravit Barkama PAIEON, INC. 22 HAMELACHA ST., P.O.B. 11355 Rosh Haayin, IL 48901 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-14 |
| Decision Date | 2007-10-10 |
| Summary: | summary |