The following data is part of a premarket notification filed by Ferrania S.p.a. Stabilimento Di Ferrania with the FDA for Lifejet Printer 400.
| Device ID | K011617 |
| 510k Number | K011617 |
| Device Name: | LIFEJET PRINTER 400 |
| Classification | Camera, Multi Format, Radiological |
| Applicant | FERRANIA S.P.A. STABILIMENTO DI FERRANIA 57 VIALE DELLA LIBERTA Ferrania, Savona, IT 17014 |
| Contact | Riccardo Genta |
| Correspondent | Chantel Carson UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-05-25 |
| Decision Date | 2001-06-08 |
| Summary: | summary |