The following data is part of a premarket notification filed by Med-western Electronics, Inc. with the FDA for Litronic Stimulator.
Device ID | K810225 |
510k Number | K810225 |
Device Name: | LITRONIC STIMULATOR |
Classification | Stimulator, Muscle, Powered |
Applicant | MED-WESTERN ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-27 |
Decision Date | 1981-03-30 |