Clearance Summary
NEUROLOGICAL SPONGE received FDA 510(k) clearance under submission number K914600, sponsored by I M, 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 1992-12-30.
- Submission: K914600
- Applicant / Sponsor: I M, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4700
- Decision date: 1992-12-30
Classification & Regulation
This clearance is catalogued under FDA product code HBA and 21 CFR 882.4700, within the Neurology review panel as a Class II device.