The following data is part of a premarket notification filed by La Jolla Technology, Inc. with the FDA for Nynex Ii.
Device ID | K830932 |
510k Number | K830932 |
Device Name: | NYNEX II |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | LA JOLLA TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-23 |
Decision Date | 1983-04-18 |