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 |
|---|---|---|---|
| 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 |
| K991884 | SIEMENS FIO2 SENSOR | Siemens Medical Solutions USA, Inc. | 1999-11-03 |
Related GUDID Devices#
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|---|---|---|---|
| 10889483588635 | Vital Signs™ | AirLife Finland Oy | 2025-04-02 |
| 10889483588673 | Vital Signs™ | AirLife Finland Oy | 2025-03-31 |
| 10889483588659 | Vital Signs™ | AirLife Finland Oy | 2025-03-31 |
| 10841522108846 | Ultraview | SPACELABS HEALTHCARE (WASHINGTON), INC | 2024-05-13 |
| 10190752191235 | Vital Signs™ | AirLife Finland Oy | 2023-05-30 |
| 10190752111349 | Vital Signs™ | Vyaire GmbH | 2021-04-02 |
| 10190752143791 | Vital Signs™ | AirLife Finland Oy | 2021-03-05 |
| 10190752143784 | Vital Signs™ | AirLife Finland Oy | 2021-03-05 |
| 10190752143777 | Vital Signs™ | AirLife Finland Oy | 2021-03-05 |
| 10190752140912 | Vital Signs™ | AirLife Finland Oy | 2021-01-28 |
| 10190752141827 | Vital Signs™ | AirLife Finland Oy | 2021-01-28 |
| 10190752140844 | Vital Signs™ | AirLife Finland Oy | 2021-01-28 |
| 10190752141810 | 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 |
| 10190752140837 | Vital Signs™ | AirLife Finland Oy | 2020-12-03 |
| 10190752110922 | Vital Signs™ | AirLife Finland Oy | 2019-09-01 |
| 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 |
| 10190752110915 | Vital Signs™ | AirLife Finland Oy | 2019-09-01 |
| 10841522107818 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-03-10 |
| 10846446065060 | BIRD SENTRY2 | Carefusion Corporation | 2017-03-01 |
| 10846446065084 | BIRD SENTRY2 | Carefusion Corporation | 2017-03-01 |
| 10846446065107 | BIRD SENTRY2 | Carefusion Corporation | 2017-03-01 |
| 10846446065121 | BIRD SENTRY2 | Carefusion Corporation | 2017-03-01 |
| 10841522113109 | Spacelabs | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-11-30 |
| 10885403248986 | Vital Signs | Carefusion Finland 320 Oy | 2016-09-14 |
| 10885403248993 | Vital Signs | Carefusion Finland 320 Oy | 2016-09-14 |
| 10885403255021 | Vital Signs | Carefusion Finland 320 Oy | 2016-09-14 |