The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Laser Sys*stim 540, Model Me 540.
| Device ID | K043586 |
| 510k Number | K043586 |
| Device Name: | LASER SYS*STIM 540, MODEL ME 540 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| 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 | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-28 |
| Decision Date | 2005-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816864020555 | K043586 | 000 |
| 00816864020548 | K043586 | 000 |
| 00816864020425 | K043586 | 000 |