The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sys Stim 294, Model Me 294.
Device ID | K984114 |
510k Number | K984114 |
Device Name: | SYS STIM 294, MODEL ME 294 |
Classification | Stimulator, Muscle, Powered |
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 | IPF |
Subsequent Product Code | GZJ |
Subsequent Product Code | LIH |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-17 |
Decision Date | 1999-02-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816864020173 | K984114 | 000 |