CAPNOGRAPHY PAD (92516)— 510(k) K121017

Substantially Equivalent

Spacelabs Healthcare

FDA 510(k) clearance K121017 for CAPNOGRAPHY PAD (92516), Substantially Equivalent on 2012-07-13. Applicant: Spacelabs Healthcare.

Clearance details

Applicant: Spacelabs Healthcare
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2012-04-04
Decision date: 2012-07-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Nederland, CO, US

Download summary PDF View on FDA.gov ↗

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.