510(k) K072843
- Device
- YG-125T AND YG-135T NASAL ADAPTER
- Applicant
- NIHON KOHDEN AMERICA, INC.
- 510(k) number
- K072843
- Product code
- CCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-11-29
- Date received
- 2007-10-04
- Regulation
- 868.1400
- Classification name
- Analyzer, Gas, Carbon-dioxide, Gaseous-phase
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JACK COGGAN
- Address
- 90 Icon St. Foothill CA US 92610 92610
FDA Registration Numbers#
- 3002807267
- 3004977335
- 3010390468
- 3008483389
- 9710602
- 8020864
- 1218950
- 3001104093
- 3013298431
- 3008363989
- 3007695715
- 9611031
- 1314417
- 3008716327
- 2028807
- 1319447
- 3004906872
- 3009973336
- 3038913749
- 9616088
- 3008729547
- 3004748541
- 3003591740
- 1319639
- 3010149039
- 2648727
- 3006534321
- 3016852448
- 3012639025
- 1066270
- 3029871637
- 3005998497
- 3006061749
- 3013783488
- 3007238566
- 3015876
- 1220908
- 3011120183
- 3001313714
- 2023529
- 1722070
- 8021995
- 3012337868
- 3007962724
- 1043214
- 3018783526
- 3016674095
- 3010887638
- 3017202422
- 9617192
- 3044156918
- 3035111606
- 3005135175
- 3012733231
- 3003589956
- 3021343210
- 9617604
- 3016964847
- 1423537
- 9681384
- 3012251275
- 2221819
- 3015168843
- 2518422
- 9610816
- 3007307487
- 8030229
- 3012528160
- 3006713849
- 3007048256
- 1526012
- 3010411911
- 9610849
- 3003687189
- 3007481893
- 3008867836
- 1450653
- 2529489
- 3003898360
- 3019388613
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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