The following data is part of a premarket notification filed by Natus Medical, Inc. with the FDA for Navigator Pro With Aep Software (biomark, Enog, Champ).
| Device ID | K083371 |
| 510k Number | K083371 |
| Device Name: | NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NATUS MEDICAL, INC. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 |
| Contact | Nicohl R Wilding |
| Correspondent | Nicohl R Wilding NATUS MEDICAL, INC. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-14 |
| Decision Date | 2009-12-08 |
| Summary: | summary |