The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for Artoscan C.
| Device ID | K040877 |
| 510k Number | K040877 |
| Device Name: | ARTOSCAN C |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ESAOTE S.P.A. 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Contact | Carri Graham |
| Correspondent | Carri Graham ESAOTE S.P.A. 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-05 |
| Decision Date | 2004-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304453396 | K040877 | 000 |
| 08056304453228 | K040877 | 000 |
| 08056304453211 | K040877 | 000 |
| 08056304453204 | K040877 | 000 |
| 08056304453198 | K040877 | 000 |
| 08056304453181 | K040877 | 000 |
| 08056304453174 | K040877 | 000 |
| 08056304453167 | K040877 | 000 |