Clearance Summary
MULTIPLEX I, INTERFERENTIAL CURRENT received FDA 510(k) clearance under submission number K841579, sponsored by Houwers Enterprises , Ltd.. 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 1984-05-10.
- Submission: K841579
- Applicant / Sponsor: Houwers Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1984-05-10
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.