The following data is part of a premarket notification filed by Metron Medical Australia Pty Ltd with the FDA for Vectorsonic, Model Vu-200.
Device ID | K020119 |
510k Number | K020119 |
Device Name: | VECTORSONIC, MODEL VU-200 |
Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
Applicant | METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria, AU 3201 |
Contact | Dave Torman |
Correspondent | Dave Torman METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria, AU 3201 |
Product Code | IMG |
CFR Regulation Number | 890.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-14 |
Decision Date | 2002-07-22 |