CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories— 510(k) K171028

Substantially Equivalent

GE Healthcare Finland Oy

FDA 510(k) clearance K171028 for CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories, Substantially Equivalent on 2017-08-17. Applicant: GE Healthcare Finland Oy.

Clearance details

Applicant: GE Healthcare Finland Oy
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2017-04-05
Decision date: 2017-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
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.