POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB.— 510(k) K051739

Substantially Equivalent

Multigon Industries, Inc.

FDA 510(k) clearance K051739 for POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB., Substantially Equivalent on 2005-07-28. Applicant: Multigon Industries, Inc..

Clearance details

Applicant: Multigon Industries, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2005-06-28
Decision date: 2005-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yonkers, NY, US

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Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.