The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Auto*therm 395, Model Me 395.
| Device ID | K022458 |
| 510k Number | K022458 |
| Device Name: | AUTO*THERM 395, MODEL ME 395 |
| Classification | Diathermy, Shortwave, 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 | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-26 |
| Decision Date | 2002-09-26 |
| Summary: | summary |