The following data is part of a premarket notification filed by Paieon, Inc. with the FDA for The Cardiop-b System.
| Device ID | K030139 |
| 510k Number | K030139 |
| Device Name: | THE CARDIOP-B SYSTEM |
| Classification | System, X-ray, Angiographic |
| Applicant | PAIEON, INC. 747 THIRD AVE., 4TH FLOOR New York, NY 10017 -2803 |
| Contact | Omer Barlev |
| Correspondent | Omer Barlev PAIEON, INC. 747 THIRD AVE., 4TH FLOOR New York, NY 10017 -2803 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-14 |
| Decision Date | 2004-04-02 |
| Summary: | summary |