Clearance Summary
PIV SYSTEM received FDA 510(k) clearance under submission number K981032, sponsored by Medical Solutions, 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 1998-09-02.
- Submission: K981032
- Applicant / Sponsor: Medical Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1998-09-02
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.