MODEL M1175A/M1176A WITH ST SEGMENT MONITORING— 510(k) K900032

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K900032 for MODEL M1175A/M1176A WITH ST SEGMENT MONITORING, Substantially Equivalent on 1990-04-10. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1990-01-02
Decision date: 1990-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.