Clearance Summary
AUTOMOVE, MODEL AM800 received FDA 510(k) clearance under submission number K032955, 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 2003-12-15.
- Submission: K032955
- Applicant / Sponsor: Danmeter A/S
- Clearance pathway: Abbreviated
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2003-12-15
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.