CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES— 510(k) K123195
Substantially EquivalentGE Healthcare Finland Oy
FDA 510(k) clearance K123195 for CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES, Substantially Equivalent on 2013-02-28. Applicant: GE Healthcare Finland Oy. Device class: 2.
Clearance details
- Applicant
- GE Healthcare Finland Oy
- Product code
- Code CCL
- Device class
- Class 2
- Regulation
- 21 CFR 868.1720
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Helsinki, FI
Recent devices under product code CCL
view allMore clearances from GE Healthcare Finland Oy
view allAdverse events under product code CCL
product code CCL- Other
- 2
- Total
- 2
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 K123195
K-number listed on FDA's recall record- Z-0754-2020 — CARESCAPE Respiratory Module E-sCO
- Z-0756-2020 — CARESCAPE Respiratory Module E-sCAiO
- Z-0757-2020 — CARESCAPE Respiratory Module E-sCAiOV
- Z-2617-2014 — CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor -Airway Gas Option N-CAiO modules with B40 Patient Monitor
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123195.
Data sourced from openFDA. This site is unofficial and independent of the FDA.