The following data is part of a premarket notification filed by Metron Medical Australia Pty Ltd with the FDA for Accusonic Advantage.
| Device ID | K124010 |
| 510k Number | K124010 |
| Device Name: | ACCUSONIC ADVANTAGE |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria, AU 3201 |
| Contact | David Mitchell |
| Correspondent | David Mitchell METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria, AU 3201 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-27 |
| Decision Date | 2013-08-23 |