Clearance Summary
ELECTRONIC GLOVE INTEGRITY MONITOR (EGIM) received FDA 510(k) clearance under submission number K932714, sponsored by Surface Mount Technology, 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 1993-12-01.
- Submission: K932714
- Applicant / Sponsor: Surface Mount Technology, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1993-12-01
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.