ADR ULTRASOUND MODELS 4000S & 4000S/L— 510(k) K813543

Name: FDA 510(k) clearance K813543
Creator: U.S. Food and Drug Administration
Published: 1982-02-24

Substantially Equivalent

Adr Ultrasound

FDA 510(k) clearance K813543 for ADR ULTRASOUND MODELS 4000S & 4000S/L, Substantially Equivalent on 1982-02-24. Applicant: Adr Ultrasound. Device class: 2.

Clearance details

Applicant: Adr Ultrasound
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 1981-12-21
Decision date: 1982-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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.