The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sonicator 715.
| Device ID | K934845 |
| 510k Number | K934845 |
| Device Name: | SONICATOR 715 |
| 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 E Fleming |
| Correspondent | Robert E 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 | 1993-10-08 |
| Decision Date | 1994-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816864020739 | K934845 | 000 |