Clearance Summary
GLOVE-CHEK PORTABLE FLUID LEAKAGE SENSING DEVICE received FDA 510(k) clearance under submission number K913696, sponsored by Vertex Technical Group, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1992-02-18.
- Submission: K913696
- Applicant / Sponsor: Vertex Technical Group, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1992-02-18
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.