The following data is part of a premarket notification filed by Metron Medical Australia Pty Ltd with the FDA for Vectorsurge 4 Interferential Therapy Unit.
Device ID | K993821 |
510k Number | K993821 |
Device Name: | VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT |
Classification | Stimulator, Muscle, Powered |
Applicant | METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria, AU 3201 |
Contact | R.h. Hopkins |
Correspondent | R.h. Hopkins METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria, AU 3201 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-12 |
Decision Date | 1999-12-09 |