The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sonicator Plus 920.
| Device ID | K111482 |
| 510k Number | K111482 |
| Device Name: | SONICATOR PLUS 920 |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| 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 | IMG |
| Subsequent Product Code | GZI |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | IPF |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-27 |
| Decision Date | 2011-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816864020654 | K111482 | 000 |
| 00816864020647 | K111482 | 000 |
| 00816864020210 | K111482 | 000 |