The following data is part of a premarket notification filed by Metron Medical Australia Pty Ltd with the FDA for Vectorsurge 5, Model Vs-500.
| Device ID | K002058 |
| 510k Number | K002058 |
| Device Name: | VECTORSURGE 5, MODEL VS-500 |
| Classification | Stimulator, Muscle, Powered |
| 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 | IPF |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-06 |
| Decision Date | 2001-05-29 |