The following data is part of a premarket notification filed by Neurologica Corporation with the FDA for Bodytom Nl 4000.
| Device ID | K102677 |
| 510k Number | K102677 |
| Device Name: | BODYTOM NL 4000 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | NEUROLOGICA CORPORATION 14 ELECTRONICS AVENUE Danvers, MA 01923 -1011 |
| Contact | Donald D Fickett |
| Correspondent | Jay Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-09-15 |
| Decision Date | 2011-03-24 |
| Summary: | summary |