The following data is part of a premarket notification filed by Metron Medical Australia Pty Ltd with the FDA for Vectorsurge 5 Model 470.
Device ID | K030648 |
510k Number | K030648 |
Device Name: | VECTORSURGE 5 MODEL 470 |
Classification | Stimulator, Muscle, Powered |
Applicant | METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria, AU 3201 |
Contact | Dave Toman |
Correspondent | Dave Toman METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria, AU 3201 |
Product Code | IPF |
Subsequent Product Code | GZJ |
Subsequent Product Code | LIH |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-28 |
Decision Date | 2003-03-28 |