The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for A-channels Lumbat Spine Coils 17; 4-channels Lumbar Spine Coils 18.
| Device ID | K110802 |
| 510k Number | K110802 |
| Device Name: | A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ESAOTE S.P.A. 11460 N MERIDIAN ST SUITE 150 Carmel, IN 46032 |
| Contact | Allison Scott |
| Correspondent | Allison Scott ESAOTE S.P.A. 11460 N MERIDIAN ST SUITE 150 Carmel, IN 46032 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-23 |
| Decision Date | 2011-04-08 |
| Summary: | summary |