Clearance Summary
BLADDERMANAGER PCI 5000 MODEL 1002 received FDA 510(k) clearance under submission number K982568, sponsored by Diagnostic Ultrasound Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1999-01-25.
- Submission: K982568
- Applicant / Sponsor: Diagnostic Ultrasound Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 1999-01-25
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.