The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sonicator 705 Model Me 705.
| Device ID | K851397 |
| 510k Number | K851397 |
| Device Name: | SONICATOR 705 MODEL ME 705 |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
| Contact | Fleming |
| Correspondent | Fleming METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-09 |
| Decision Date | 1985-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816864020715 | K851397 | 000 |