CCL — Analyzer, Gas, Oxygen, Gaseous-Phase Class II
FDA product code CCL covers "Analyzer, Gas, Oxygen, Gaseous-Phase", a Class II medical device regulated under 21 CFR 868.1720. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CCL
- Device Class
- Class II
- Regulation Number
- 868.1720
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251245 | bio-med device | OxyMinder Pro (10310) | August 11, 2025 |
| K250002 | life spark medical | Smart Check O2 (MA0236) | April 24, 2025 |
| K221734 | maxtec | Maxtec MaxO2 ME+p | April 1, 2023 |
| K213933 | careox | Percent Oxygen Sensors | August 19, 2022 |
| K213948 | bio-med devices | OxyMinder | March 17, 2022 |
| K173807 | precision medical | Accu O2 Oxygen Analyzer | May 2, 2018 |
| K153659 | maxtec | MaxO2ME | June 10, 2016 |
| K123195 | ge healthcare finland | CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES | February 28, 2013 |
| K122290 | envitec-wismar | ENVITEC MYSIGN O OXYGEN MEASURING DEVICE | January 23, 2013 |
| K112402 | maxtec | ULTRAMAXO2 OXYGEN ANALYER | December 14, 2011 |
| K082655 | envitec-wismar | ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM | November 25, 2008 |
| K072469 | digiflo | DIGIFLO CONCENTRATOR ANALYZER | January 3, 2008 |
| K063096 | precision medical | PRECISION OXYGEN MONITOR | February 27, 2007 |
| K063488 | maxtec | MAXO2 CU | February 22, 2007 |
| K053407 | analytical industries | OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M | April 5, 2006 |
| K051092 | ge healthcare | DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV | May 25, 2005 |
| K041773 | city technology limited | OXYGEN MEDICELS, CITICELS | July 15, 2004 |
| K040484 | maxtec | MAXO2+, MODEL A AND AE | June 9, 2004 |
| K024155 | teledyne analytical instruments | MX 300 OXYGEN MONITOR | July 17, 2003 |
| K024228 | teledyne analytical instruments | RX300 OXYGEN ANALYZER | July 17, 2003 |