The following data is part of a premarket notification filed by Paieon, Inc. with the FDA for Ic-pro System, Version 3.1.0.4.
| Device ID | K082907 |
| 510k Number | K082907 |
| Device Name: | IC-PRO SYSTEM, VERSION 3.1.0.4 |
| Classification | System, X-ray, Angiographic |
| Applicant | PAIEON, INC. 22 HAMELACHA ST., P.O.B. 11355 Rosh Haayin, IL 48901 |
| Contact | Shahar Mandelboim |
| Correspondent | Shahar Mandelboim 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-30 |
| Decision Date | 2008-11-18 |
| Summary: | summary |