GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM— 510(k) K000695

Substantially Equivalent

Ge Medical Systems, Inc.

FDA 510(k) clearance K000695 for GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM, Substantially Equivalent on 2000-03-16. Applicant: Ge Medical Systems, Inc..

Clearance details

Applicant: Ge Medical Systems, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2000-03-01
Decision date: 2000-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, 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.