SONOGRAF EDP REAL-TIME ADAPTER— 510(k) K780578

Name: FDA 510(k) clearance K780578
Creator: U.S. Food and Drug Administration
Published: 1978-05-25

Substantially Equivalent

Foley, Lardner, Hollabaugh & Jacobs

FDA 510(k) clearance K780578 for SONOGRAF EDP REAL-TIME ADAPTER, Substantially Equivalent on 1978-05-25. Applicant: Foley, Lardner, Hollabaugh & Jacobs. Device class: 2.

Clearance details

Applicant: Foley, Lardner, Hollabaugh & Jacobs
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 1978-04-10
Decision date: 1978-05-25
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.