Clearance Summary
ACU-HALT received FDA 510(k) clearance under submission number K945374, sponsored by Eva-Health USA, 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 1995-08-09.
- Submission: K945374
- Applicant / Sponsor: Eva-Health USA, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1995-08-09
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.