The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sys*stim 220.
Device ID | K883080 |
510k Number | K883080 |
Device Name: | SYS*STIM 220 |
Classification | Interferential Current Therapy |
Applicant | METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
Contact | Robert E Fleming |
Correspondent | Robert E Fleming METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
Product Code | LIH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-21 |
Decision Date | 1989-04-27 |