CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO— 510(k) K183394

Substantially Equivalent

GE Healthcare Finland Oy

FDA 510(k) clearance K183394 for CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, Substantially Equivalent on 2019-05-01. Applicant: GE Healthcare Finland Oy.

Clearance details

Applicant: GE Healthcare Finland Oy
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2018-12-07
Decision date: 2019-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Helsinki, FI

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.