CAPNO MODULE, 92517— 510(k) K130112

Name: FDA 510(k) clearance K130112
Creator: U.S. Food and Drug Administration
Published: 2013-03-21

Substantially Equivalent

Spacelabs Healthcare

FDA 510(k) clearance K130112 for CAPNO MODULE, 92517, Substantially Equivalent on 2013-03-21. Applicant: Spacelabs Healthcare. Device class: 2.

Clearance details

Applicant: Spacelabs Healthcare
Product code: Code CCK
Device class: Class 2
Regulation: 21 CFR 868.1400
Advisory panel: Anesthesiology
Date received: 2013-01-16
Decision date: 2013-03-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Nederland, CO, US

Download summary PDF View on FDA.gov ↗

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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.