CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories
FDA 510(k) K211171 · GE Healthcare Finland Oy
510(k) numberK211171
Submission
- Device name
- CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories
- Applicant
- GE Healthcare Finland Oy
Helsinki, FI - Received
- April 19, 2021
- Decision date
- October 21, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251641 | GF-310R Multigas Unit (GF-310R)CCK · Traditional | Nihon Kohden Corporation | 08/12/2026SE |
| K261633 | VisuBreathCCK · Traditional | Affirm Medical Technologies II, LLC | 07/14/2026SE |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN)CCK · Traditional | Covidien, LLC | 05/01/2026SE |
| K250148 | Medical Gas Analyzer (AG200)CCK · Traditional | Prior Care Science Technology, Ltd. | 08/28/2025SE |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK · Traditional | Nihon Kohden Corporation | 06/10/2025SE |
| K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2…CCK · Traditional | Barbaras Development, Inc. | 06/04/2025SE |
| K240937 | Aim (N/A)CCK · Traditional | Inventeur, LLC | 12/16/2024SE |
| K230915 | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen MaskCCK · Traditional | Vyaire Medical, Inc. | 11/12/2024SE |
| K212425 | MicroTrend SystemCCK · Traditional | Exostat Medical, Inc. | 11/07/2024SE |
| K222511 | Oxy2ProCCK · Traditional | Southmedic, Inc. | 11/21/2023SE |
More from Southmedic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…MHX · Traditional | 09/01/2026SE |
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart DisplayMHX · Traditional | 08/28/2026SE |
| K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame…MHX · Traditional | 04/06/2023SE |
| K213363 | CARESCAPE B450, E-musbMHX · Traditional | 04/13/2022SE |
| K213336 | Carescape B850, E-musbMHX · Traditional | 04/13/2022SE |
| K213181 | CARESCAPE B650, E-musbMHX · Traditional | 04/13/2022SE |
| K191323 | Carescape B850MHX · Traditional | 01/29/2020SE |
| K191249 | Carescape B450MHX · Traditional | 01/24/2020SE |
| K191322 | E-Eegx, N-EegxOLT · Traditional | 01/22/2020SE |
| K191149 | Carescape B650MHX · Traditional | 01/21/2020SE |
Questions and answers
When was CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories cleared by the FDA?
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories (K211171) received a 510(k) decision of Substantially Equivalent on October 21, 2021, 185 days after the submission was received.
What is the product code of K211171?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.