CODEMASTER XL + XL W/SHOCK ADVISORY OPTION— 510(k) K954957

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K954957 for CODEMASTER XL + XL W/SHOCK ADVISORY OPTION, Substantially Equivalent on 1996-05-07. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 1995-10-27
Decision date: 1996-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcminnville, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

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.