The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sys*stim 207 Model Me 207.
Device ID | K853750 |
510k Number | K853750 |
Device Name: | SYS*STIM 207 MODEL ME 207 |
Classification | Stimulator, Muscle, Powered |
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 | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-09 |
Decision Date | 1985-11-26 |