DOPPLER IMAGING OPTION— 510(k) K840140

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K840140 for DOPPLER IMAGING OPTION, Substantially Equivalent on 1984-08-23. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code IYN
Advisory panel: Radiology
Date received: 1984-01-04
Decision date: 1984-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.