SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM— 510(k) K970034

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K970034 for SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM, Substantially Equivalent on 1997-03-17. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1997-01-03
Decision date: 1997-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.