Clearance Summary
ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 received FDA 510(k) clearance under submission number K032954, sponsored by Danmeter A/S. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2004-08-09.
- Submission: K032954
- Applicant / Sponsor: Danmeter A/S
- Clearance pathway: Abbreviated
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2004-08-09
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.