The following data is part of a premarket notification filed by Neurologica Corporation with the FDA for Inspira Hd, Model: Nl1000.
| Device ID | K090811 |
| 510k Number | K090811 |
| Device Name: | INSPIRA HD, MODEL: NL1000 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | NEUROLOGICA CORPORATION 14 ELECTRONICS AVENUE Danvers, MA 01923 -1011 |
| Contact | Donald D Fickett |
| Correspondent | Donald D Fickett NEUROLOGICA CORPORATION 14 ELECTRONICS AVENUE Danvers, MA 01923 -1011 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-25 |
| Decision Date | 2009-08-27 |
| Summary: | summary |