The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sys*stim 240.
| Device ID | K113017 |
| 510k Number | K113017 |
| Device Name: | SYS*STIM 240 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
| Contact | Christina Cayuela |
| Correspondent | Christina Cayuela METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
| Product Code | IPF |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | ILY |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-11 |
| Decision Date | 2012-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816864020586 | K113017 | 000 |
| 00816864020579 | K113017 | 000 |
| 00816864020166 | K113017 | 000 |