The following data is part of a premarket notification filed by Diacardio, Ltd with the FDA for Lvivo Ef System.
| Device ID | K130779 |
| 510k Number | K130779 |
| Device Name: | LVIVO EF SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | DIACARDIO, LTD 291 HILLSIDE AVE. Somerset, MA 02726 |
| Contact | George Hattub |
| Correspondent | George Hattub DIACARDIO, LTD 291 HILLSIDE AVE. Somerset, MA 02726 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-21 |
| Decision Date | 2013-08-15 |
| Summary: | summary |