PORTABLE MEDICAL ULTRASOUND SCANNER— 510(k) K800434

Substantially Equivalent

Bion Ent., Ltd.

FDA 510(k) clearance K800434 for PORTABLE MEDICAL ULTRASOUND SCANNER, Substantially Equivalent on 1980-04-10. Applicant: Bion Ent., Ltd..

Clearance details

Applicant: Bion Ent., Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1980-02-27
Decision date: 1980-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.