SPACELABS ARKON ANESTHESIA WORKSTATION— 510(k) K113051

Substantially Equivalent

Spacelabs Healthcare

FDA 510(k) clearance K113051 for SPACELABS ARKON ANESTHESIA WORKSTATION, Substantially Equivalent on 2012-03-22. Applicant: Spacelabs Healthcare.

Clearance details

Applicant: Spacelabs Healthcare
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2011-10-13
Decision date: 2012-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nederland, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.