510(k) K140113
- Device
- O2 NASAL CANNULA WITH CO2 MONITORING
- Applicant
- FLEXICARE MEDICAL LTD.
- 510(k) number
- K140113
- Product code
- CCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-03-06
- Date received
- 2014-01-15
- Regulation
- 868.1400
- Classification name
- Analyzer, Gas, Carbon-dioxide, Gaseous-phase
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- CHRIS WATKINS
- Address
- Cynon Valley Business Park Moutain Ash Mid Glamorgan GB CF45 4ER CF45 4ER
FDA Registration Numbers#
- 3005135175
- 3007048256
- 8030229
- 3010223399
- 1314417
- 3009607734
- 3013679558
- 3012251275
- 3009156722
- 3006061749
- 3015876
- 3006536657
- 3003630387
- 3007962724
- 3003832357
- 3016964847
- 3015997711
- 3001570235
- 3013652261
- 3009499478
- 3011353843
- 3007307487
- 3016674095
- 1526012
- 3000126629
- 3030733800
- 2221819
- 3004365956
- 3003263092
- 3013513837
- 3005783425
- 2183646
- 3014541700
- 3010419931
- 3003591740
- 3045323840
- 2936999
- 1220908
- 9710116
- 3006307105
- 3010683054
- 3011120183
- 3008058135
- 3005877899
- 3009327445
- 3016618143
- 3009490946
- 3012307300
- 3018094310
- 9710567
- 3016852448
- 3010526986
- 3013298431
- 3006979678
- 3006606984
- 1066270
- 9611252
- 3006807694
- 9617566
- 3021559257
- 3005998497
- 3010703925
- 1000122786
- 3011503227
- 8044004
- 3008716327
- 8022257
- 3031158
- 3006547005
- 3038259592
- 3006606827
- 3009129579
- 9616088
- 9615102
- 3004906872
- 3007238566
- 9611500
- 3011987967
- 3008264255
- 9611031
Source Documents#
Other 510(k) Records For Product Code CCK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261633 | VisuBreath | Affirm Medical Technologies II, LLC | 2026-07-14 |
| K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | 2026-05-01 |
| K250148 | Medical Gas Analyzer (AG200) | Prior Care Science Technology, Ltd. | 2025-08-28 |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | Nihon Kohden Corporation | 2025-06-10 |
| K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line | Barbaras Development, Inc. | 2025-06-04 |
| K240937 | AIM (N/A) | Inventeur, LLC | 2024-12-16 |
| K230915 | AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask | Vyaire Medical, Inc. | 2024-11-12 |
| K212425 | MicroTrend System | Exostat Medical, Inc. | 2024-11-07 |
| K222511 | Oxy2Pro | Southmedic, Inc. | 2023-11-21 |
| K213767 | Endure ETCO2/02 Nasal Cannula | Endure Industries, Inc. | 2023-09-12 |
| K221118 | CO2 Mainstream Sensor | Draegerwerk AG & CO Kgaa | 2023-04-05 |
| K210112 | XChange Device, XChange System | Pneuma Therapeutics, Inc. | 2023-01-30 |
| K220533 | Endoscopy Oxygen Mask | Engineered Medical Systems, Inc. | 2022-11-16 |
| K213911 | Microstream CO2 NanoPod | Covidien, LLC | 2022-07-29 |
| K213518 | CARESCAPE CO2 Microstream parameter | Covidien, LLC | 2022-04-12 |
Legacy Summary#
summary
FDA Review#
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