Clearance Summary
HP M2376A DEVICE LINK SYSTEM received FDA 510(k) clearance under submission number K984194, sponsored by Hewlett-Packard Co.. 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 1999-04-30.
- Submission: K984194
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1999-04-30
Classification & Regulation
This clearance is catalogued under FDA product code MQS and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.