SAECG CARDIOGRAPH MODEL M1754A— 510(k) K913997

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K913997 for SAECG CARDIOGRAPH MODEL M1754A, Substantially Equivalent on 1992-03-06. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1991-09-06
Decision date: 1992-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcminnville, OR, US

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Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.