Clearance Summary
FX-2P NMS (2 CHANNEL PORTABLE) received FDA 510(k) clearance under submission number K945508, sponsored by Fx-2. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1995-05-02.
- Submission: K945508
- Applicant / Sponsor: Fx-2
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1995-05-02
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.