Product code CCL
- Device name
- Analyzer, Gas, Oxygen, Gaseous-Phase
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1720
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | Salter Labs | 2026-07-30 |
| K251245 | OxyMinder Pro (10310) | Bio-Med Device, Inc. | 2025-08-11 |
| K250002 | Smart Check O2 (MA0236) | Life Spark Medical, LLC | 2025-04-24 |
| K221734 | Maxtec MaxO2 ME+p | Maxtec, LLC | 2023-04-01 |
| K213933 | Percent Oxygen Sensors | Careox, LLC | 2022-08-19 |
| K213948 | OxyMinder | Bio-Med Devices, Inc. | 2022-03-17 |
| K173807 | Accu O2 Oxygen Analyzer | Precision Medical, Inc. | 2018-05-02 |
| K153659 | MaxO2ME | Maxtec, LLC | 2016-06-10 |
| K123195 | CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES | GE Healthcare Finland Oy | 2013-02-28 |
| K122290 | ENVITEC MYSIGN O OXYGEN MEASURING DEVICE | Envitec-Wismar GmbH | 2013-01-23 |
| K112402 | ULTRAMAXO2 OXYGEN ANALYER | Maxtec, LLC | 2011-12-14 |
| K082655 | ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 | Envitec-Wismar GmbH | 2008-11-25 |
| K072469 | DIGIFLO CONCENTRATOR ANALYZER | Digiflo, Inc. | 2008-01-03 |
| K063096 | PRECISION OXYGEN MONITOR | Precision Medical, Inc. | 2007-02-27 |
| K063488 | MAXO2 CU | Maxtec, Inc. | 2007-02-22 |
| K053407 | OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M | Analytical Industries, Inc. | 2006-04-05 |
| K051092 | DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC | GE Healthcare | 2005-05-25 |
| K041773 | OXYGEN MEDICELS, CITICELS | City Technology Limited | 2004-07-15 |
| K040484 | MAXO2+, MODEL A AND AE | Maxtec, Inc. | 2004-06-09 |
| K024155 | MX 300 OXYGEN MONITOR | Teledyne Analytical Instruments | 2003-07-17 |
| K024228 | RX300 OXYGEN ANALYZER | Teledyne Analytical Instruments | 2003-07-17 |
| K023565 | OXICHECK | Caradyne, Ltd. | 2003-03-28 |
| K010318 | PRIMA OXYGEN MONITOR | Penlon , Ltd. | 2001-07-23 |
| K002382 | 'ALL 2000' % OXYGEN ANALYZER | Analytical Industries, Inc. | 2001-03-14 |
| K010382 | 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I | Sensidyne, Inc. | 2001-03-01 |
| K002384 | M-XX OXYGEN SENSORS | International Business Strategies | 2000-12-15 |
| K000700 | SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR | Sensidyne, Inc. | 2000-08-31 |
| K001095 | OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130 | Teledyne Analytical Instruments | 2000-06-30 |
| K990403 | TED 200T7 OXYGEN MONITOR | Teledyne Electronic Technologies | 2000-02-03 |
| K990457 | TED 60T OXYGEN ANALYZER | Teledyne Electronic Technologies | 1999-11-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04036616011846 | Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 2026-08-19 |
| 04036616011839 | Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 2026-08-19 |
| 04036616013482 | Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 2026-08-19 |
| 04036616011976 | Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 2026-08-19 |
| 04036616011969 | Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 2026-08-19 |
| 04036616011952 | Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 2026-08-19 |
| 04036616011945 | Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 2026-08-19 |
| 04036616011938 | Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 2026-08-19 |
| 04036616011921 | Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 2026-08-19 |
| 04036616011914 | Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 2026-08-19 |
| 04036616011907 | Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 2026-08-19 |
| 04036616011891 | Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 2026-08-19 |
| 04036616011884 | Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 2026-08-19 |
| 04036616011877 | Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 2026-08-19 |
| 04036616011860 | Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 2026-08-19 |
| 10190752111349 | Vital Signs™ | Vyaire GmbH | 2021-04-02 |
| 10190752143784 | Vital Signs™ | AirLife Finland Oy | 2021-03-05 |
| 10190752143777 | Vital Signs™ | AirLife Finland Oy | 2021-03-05 |
| 10190752140844 | Vital Signs™ | AirLife Finland Oy | 2021-01-28 |
| 10190752140912 | Vital Signs™ | AirLife Finland Oy | 2021-01-28 |
| 10190752141827 | Vital Signs™ | AirLife Finland Oy | 2021-01-28 |
| 10190752140837 | Vital Signs™ | AirLife Finland Oy | 2020-12-03 |
| 10190752140868 | Vital Signs™ | AirLife Finland Oy | 2020-12-03 |
| 10190752140875 | Vital Signs™ | AirLife Finland Oy | 2020-12-03 |
| 10190752141810 | Vital Signs™ | AirLife Finland Oy | 2020-12-03 |
| 10190752117174 | Vital Signs™ | AirLife Finland Oy | 2019-09-01 |
| 10190752117181 | Vital Signs™ | AirLife Finland Oy | 2019-09-01 |
| 10190752117495 | Vital Signs™ | AirLife Finland Oy | 2019-09-01 |
| 10190752110922 | Vital Signs™ | AirLife Finland Oy | 2019-09-01 |
| 10190752110915 | Vital Signs™ | AirLife Finland Oy | 2019-09-01 |