Clearance Summary
ACTIWATCH received FDA 510(k) clearance under submission number K983533, sponsored by Mini-Mitter Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1999-03-23.
- Submission: K983533
- Applicant / Sponsor: Mini-Mitter Co., Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 1999-03-23
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.