CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO— 510(k) K183394
Substantially EquivalentGE 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. Device class: 2.
Clearance details
- Applicant
- GE Healthcare Finland Oy
- Product code
- Code CCK
- Device class
- Class 2
- Regulation
- 21 CFR 868.1400
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Helsinki, FI
Recent devices under product code CCK
view allMore clearances from GE Healthcare Finland Oy
view allAdverse events under product code CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K183394
K-number listed on FDA's recall record- Z-0754-2020 — CARESCAPE Respiratory Module E-sCO
- Z-0755-2020 — CARESCAPE Respiratory Module E-sCOVX
- Z-0756-2020 — CARESCAPE Respiratory Module E-sCAiO
- Z-0757-2020 — CARESCAPE Respiratory Module E-sCAiOV
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183394.
Data sourced from openFDA. This site is unofficial and independent of the FDA.