510(k) K944485— 4000 AU ULTRASOUND IMAGING SYSTEM

Substantially Equivalent

Biosound, Inc.

Clearance details

Applicant: Biosound, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1994-09-13
Decision date: 1995-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.