MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION— 510(k) K910291

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K910291 for MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION, Substantially Equivalent on 1991-04-22. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1991-01-23
Decision date: 1991-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcminnville, OR, US

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Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.