Clearance Summary
ACU-HALT received FDA 510(k) clearance under submission number K955661, sponsored by Glederer & Co., 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 1996-12-30.
- Submission: K955661
- Applicant / Sponsor: Glederer & Co., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1996-12-30
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.