The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sys*stim 208 And 208a.
Device ID | K031017 |
510k Number | K031017 |
Device Name: | SYS*STIM 208 AND 208A |
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 |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-31 |
Decision Date | 2003-05-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816864020104 | K031017 | 000 |
00816864020098 | K031017 | 000 |