The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Traveler Lt.
Device ID | K862690 |
510k Number | K862690 |
Device Name: | TRAVELER LT |
Classification | Stimulator, Electrical, Evoked Response |
Applicant | BIO-LOGIC SYSTEMS CORP. 425 HUEHL RD. Northbrook, IL 60062 |
Contact | Raviv, Ph.d. |
Correspondent | Raviv, Ph.d. BIO-LOGIC SYSTEMS CORP. 425 HUEHL RD. Northbrook, IL 60062 |
Product Code | GWF |
CFR Regulation Number | 882.1870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-15 |
Decision Date | 1986-11-25 |