The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sonicator Plus 930, Model Me 930.
| Device ID | K013192 |
| 510k Number | K013192 |
| Device Name: | SONICATOR PLUS 930, MODEL ME 930 |
| 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 |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | IPF |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-25 |
| Decision Date | 2001-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816864020227 | K013192 | 000 |