K963585

Substantially Equivalent

BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000

Applicant: Diagnostic Ultrasound Corp.
Product code: IYO
Advisory panel: Radiology
Date received: 1996-09-09
Decision date: 1996-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.