Clearance Summary
EC-7701 FLUID WARMING CABINET received FDA 510(k) clearance under submission number K993797, sponsored by Enthermics Medical Systems, 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 2000-01-20.
- Submission: K993797
- Applicant / Sponsor: Enthermics Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 2000-01-20
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.