Clearance Summary
ACTIWARE-PLMS received FDA 510(k) clearance under submission number K011430, sponsored by Mini-Mitter Co., Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-05-31.
- Submission: K011430
- Applicant / Sponsor: Mini-Mitter Co., Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2001-05-31
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.