Clearance Summary
ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 received FDA 510(k) clearance under submission number K040554, sponsored by Manufacturing Technology, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2004-07-16.
- Submission: K040554
- Applicant / Sponsor: Manufacturing Technology, Inc.
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2004-07-16
Classification & Regulation
This clearance is catalogued under FDA product code GWQ and 21 CFR 882.1400, within the Neurology review panel as a Class II device.