The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sonicator 740, Model Me 740.
| Device ID | K053546 |
| 510k Number | K053546 |
| Device Name: | SONICATOR 740, MODEL ME 740 |
| Classification | Ultrasonic Diathermy 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 | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-20 |
| Decision Date | 2006-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816864020623 | K053546 | 000 |
| 00816864020616 | K053546 | 000 |
| 00816864020609 | K053546 | 000 |
| 00816864020203 | K053546 | 000 |