The following data is part of a premarket notification filed by Metron Medical Australia Pty Ltd with the FDA for Modification To:accusonic Plus, Model Ap-100.
| Device ID | K011955 |
| 510k Number | K011955 |
| Device Name: | MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 |
| 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 | Rob Hopkins |
| Correspondent | Rob Hopkins 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-22 |
| Decision Date | 2001-07-16 |