SONOQUICK ULTRASOUND GEL— 510(k) K931908

Name: FDA 510(k) clearance K931908
Creator: U.S. Food and Drug Administration
Published: 1994-09-29

Substantially Equivalent

Sonomed Technology, Inc.

FDA 510(k) clearance K931908 for SONOQUICK ULTRASOUND GEL, Substantially Equivalent on 1994-09-29. Applicant: Sonomed Technology, Inc.. Device class: 2.

Clearance details

Applicant: Sonomed Technology, Inc.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 1993-04-16
Decision date: 1994-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: State College, PA, 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.