HP CATHSTATION - MODEL M1264B— 510(k) K961401

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K961401 for HP CATHSTATION - MODEL M1264B, Substantially Equivalent on 1996-10-08. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1996-04-11
Decision date: 1996-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.