The following data is part of a premarket notification filed by Metron Medical Australia, Pty, Ltd. with the FDA for Accousonic, Model As-270.
| Device ID | K030878 |
| 510k Number | K030878 |
| Device Name: | ACCOUSONIC, MODEL AS-270 |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | METRON MEDICAL AUSTRALIA, PTY, LTD. 57 ASTER AVE., P.O. BOX 2164 Carrum Downs, Victoria, AU 3201 |
| Contact | Dave Toman |
| Correspondent | Dave Toman METRON MEDICAL AUSTRALIA, PTY, LTD. 57 ASTER AVE., P.O. BOX 2164 Carrum Downs, Victoria, AU 3201 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-20 |
| Decision Date | 2003-03-28 |