The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Emg Navigator & Emg Traveler.
| Device ID | K893130 |
| 510k Number | K893130 |
| Device Name: | EMG NAVIGATOR & EMG TRAVELER |
| Classification | Electromyograph, Diagnostic |
| Applicant | BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
| Contact | Raviv, Ph.d. |
| Correspondent | Raviv, Ph.d. BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-25 |
| Decision Date | 1990-03-20 |