Clearance Summary
STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF received FDA 510(k) clearance under submission number K001705, sponsored by Chester Labs, 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 2000-06-29.
- Submission: K001705
- Applicant / Sponsor: Chester Labs, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1275
- Decision date: 2000-06-29
Classification & Regulation
This clearance is catalogued under FDA product code GYB and 21 CFR 882.1275, within the Neurology review panel as a Class II device.