Clearance Summary
SURGIC-ALERT MONITOR received FDA 510(k) clearance under submission number K930514, sponsored by Novatec Medical Products, Inc.--Glove Monitor. 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 1993-08-19.
- Submission: K930514
- Applicant / Sponsor: Novatec Medical Products, Inc.--Glove Monitor
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1993-08-19
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.