HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE— 510(k) K903771

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K903771 for HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE, Substantially Equivalent on 1991-02-19. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1990-08-20
Decision date: 1991-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 7030 Boblingen, DE

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Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.