The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sys Stim 206 Model Me206.
Device ID | K851735 |
510k Number | K851735 |
Device Name: | SYS STIM 206 MODEL ME206 |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
Contact | Rob Fleming |
Correspondent | Rob Fleming METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-25 |
Decision Date | 1985-11-19 |