VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE— 510(k) K963315

Substantially Equivalent

Vingmed Sound, Inc.

FDA 510(k) clearance K963315 for VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE, Substantially Equivalent on 1997-03-17. Applicant: Vingmed Sound, Inc..

Clearance details

Applicant: Vingmed Sound, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1996-08-22
Decision date: 1997-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Williamsburg, VA, 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.