VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600— 510(k) K082456

Substantially Equivalent

Verathon Incorporated

FDA 510(k) clearance K082456 for VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600, Substantially Equivalent on 2008-12-01. Applicant: Verathon Incorporated.

Clearance details

Applicant: Verathon Incorporated
Product code: Code IYO
Advisory panel: Radiology
Date received: 2008-08-26
Decision date: 2008-12-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bothell, WA, US

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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.