The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Neurovision Jjb System.
Device ID | K072343 |
510k Number | K072343 |
Device Name: | NEUROVISION JJB SYSTEM |
Classification | Stimulator, Electrical, Evoked Response |
Applicant | NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121 |
Contact | Laetitia Cousin |
Correspondent | Laetitia Cousin NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121 |
Product Code | GWF |
CFR Regulation Number | 882.1870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-21 |
Decision Date | 2007-10-29 |
Summary: | summary |