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 |