The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sonicator Plus.
| Device ID | K921436 |
| 510k Number | K921436 |
| Device Name: | SONICATOR PLUS |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
| Contact | Robert Fleming |
| Correspondent | Robert Fleming METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
| Product Code | IMG |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-25 |
| Decision Date | 1993-04-27 |