510(k) K070128
- Device
- CO2 EASY
- Applicant
- Westmed, Inc.
- 510(k) number
- K070128
- Product code
- CCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-02-15
- Date received
- 2007-01-16
- 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
- Statement
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- DALE BICKLEY
- Address
- 5580 S Nogales Hwy. Tucson AZ US 85706 85706
FDA Registration Numbers#
- 3019388613
- 3044994756
- 3004906872
- 3027256461
- 1066270
- 3030446844
- 9611500
- 1650347
- 3010272829
- 8022032
- 9710644
- 3012421607
- 3009001657
- 3007481893
- 3043226252
- 3013557562
- 9611252
- 3012337868
- 3013826848
- 3016678045
- 3017844574
- 3012359877
- 2529489
- 3029871637
- 3003879246
- 3033959233
- 3003800159
- 3007305624
- 2023529
- 3004055954
- 3017422354
- 1526012
- 2134752
- 1314417
- 3009129579
- 3013652261
- 3005767446
- 3006733253
- 2016493
- 3010703925
- 3044156918
- 3005587132
- 3003687189
- 3010411911
- 1218950
- 3020460367
- 2025816
- 3023272766
- 3005783425
- 3031887985
- 9710567
- 3045323840
- 3010317211
- 3010419931
- 3010817335
- 3006125362
- 3003674698
- 1219324
- 3010149039
- 3004016520
- 1062836
- 3030733800
- 1061124
- 3010887638
- 3012528160
- 3013060098
- 3015876
- 3014541700
- 3004748541
- 3007413079
- 3009754460
- 3013298431
- 3007695715
- 3003630387
- 3035111606
- 3011120183
- 3010223399
- 3013187142
- 3001570235
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CCK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251641 | GF-310R Multigas Unit (GF-310R) | Nihon Kohden Corporation | 2026-08-12 |
| 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 |
Legacy Summary#
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FDA Review#
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