Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories
FDA 510(k) K123195 · GE Healthcare Finland Oy
510(k) numberK123195
Submission
- Device name
- Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories
- Applicant
- GE Healthcare Finland Oy
Helsinki, FI - Received
- October 11, 2012
- Decision date
- February 28, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCL – Analyzer, Gas, Oxygen, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1720
- Specialty
- Anesthesiology
Other 510(k)s with product code CCL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)CCL · Traditional | Salter Labs | 07/30/2026SE |
| K251245 | OxyMinder Pro (10310)CCL · Traditional | Bio-Med Device, Inc. | 08/11/2025SE |
| K250002 | Smart Check O2 (MA0236)CCL · Traditional | Life Spark Medical, LLC | 04/24/2025SE |
| K221734 | Maxtec MaxO2 ME+pCCL · Traditional | Maxtec, LLC | 04/01/2023SE |
| K213933 | Percent Oxygen SensorsCCL · Traditional | Careox, LLC | 08/19/2022SE |
| K213948 | OxyMinderCCL · Traditional | Bio-Med Devices, Inc. | 03/17/2022SE |
| K173807 | Accu O2 Oxygen AnalyzerCCL · Abbreviated | Precision Medical, Inc. | 05/02/2018SE |
| K153659 | MaxO2MECCL · Traditional | Maxtec, LLC | 06/10/2016SE |
| K122290 | Envitec Mysign O Oxygen Measuring DeviceCCL · Traditional | Envitec-Wismar GmbH | 01/23/2013SE |
| K112402 | ULTRAMAXO2 Oxygen AnalyerCCL · Abbreviated | Maxtec, LLC | 12/14/2011SE |
More from Maxtec, LLC
| 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 |
| K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX…CCK · Traditional | 10/21/2021SE |
| K191323 | Carescape B850MHX · Traditional | 01/29/2020SE |
| K191249 | Carescape B450MHX · Traditional | 01/24/2020SE |
| K191322 | E-Eegx, N-EegxOLT · Traditional | 01/22/2020SE |
Questions and answers
When was Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories cleared by the FDA?
Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories (K123195) received a 510(k) decision of Substantially Equivalent on February 28, 2013, 140 days after the submission was received.
What is the product code of K123195?
The FDA product code is CCL – Analyzer, Gas, Oxygen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1720.