Clearance Summary
HEART PACK III received FDA 510(k) clearance under submission number K914933, sponsored by Westmark Hospital Supplies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1992-01-31.
- Submission: K914933
- Applicant / Sponsor: Westmark Hospital Supplies
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1992-01-31
Classification & Regulation
This clearance is catalogued under FDA product code KOD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.