EMISONIC 4201— 510(k) K781051

Substantially Equivalent

Emi Medical, Inc.

FDA 510(k) clearance K781051 for EMISONIC 4201, Substantially Equivalent on 1978-07-17. Applicant: Emi Medical, Inc..

Clearance details

Applicant: Emi Medical, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1978-06-22
Decision date: 1978-07-17
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.