The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sonicator Plus 992, Model Number Me 992 And Sonicator Plus 994, Model Number Me 994.
| Device ID | K984142 |
| 510k Number | K984142 |
| Device Name: | SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994 |
| 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 | 1998-11-18 |
| Decision Date | 1999-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816864020630 | K984142 | 000 |
| 00816864020258 | K984142 | 000 |
| 00816864020241 | K984142 | 000 |