HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02— 510(k) K896030

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K896030 for HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02, Substantially Equivalent on 1989-12-22. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1989-10-17
Decision date: 1989-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.