510(k) K003260
K003260 is an FDA 510(k) premarket notification submitted by Metron Medical Australia, Pty, Ltd. for the device "VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460". The FDA issued a decision of Substantially Equivalent on February 22, 2001. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Metron Medical Australia, Pty, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2001
- Date Received
- October 18, 2000
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type