510(k) K911970
- Device
- NASAL/ORAL 02 DELIVERY AND GAS SAMPLING DEVICE
- Applicant
- NASORCAP ENT., INC.
- 510(k) number
- K911970
- Product code
- CCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-08-14
- Date received
- 1991-05-03
- 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
- No
Applicant Contact#
- Contact
- STEVEN J DERRICK
- Address
- 1077 Huston Dr. West Mifflin PA US 15122 15122
FDA Registration Numbers#
- 3004016520
- 9611500
- 9610849
- 3015997711
- 3010703925
- 3006536657
- 1024404
- 3003832357
- 3007962724
- 3013298431
- 3010427901
- 3013513837
- 3016701404
- 3010317211
- 3014579161
- 3030446844
- 2648727
- 8020864
- 1066270
- 3003879246
- 3010419931
- 3004748541
- 9611252
- 3016674095
- 3012359877
- 3014479313
- 3006807694
- 9710567
- 3008483389
- 3007603826
- 8044169
- 3030733800
- 3009973336
- 3009327445
- 1450653
- 3004977335
- 3009129579
- 9610816
- 1220908
- 3008058135
- 3009831876
- 3008264255
- 2028807
- 9610105
- 3009156722
- 3033959233
- 3016964847
- 3003898360
- 3008716327
- 3017202422
- 1650347
- 9617566
- 9616088
- 2936999
- 3035111606
- 3006606984
- 3011120183
- 3003263092
- 3013500228
- 3011353843
- 3001104093
- 3003687189
- 3003800159
- 3017178358
- 3004055954
- 3005587132
- 1061124
- 3021343210
- 3018094310
- 1043214
- 3008729547
- 3031887985
- 3008867836
- 9710116
- 3027256461
- 3012421607
- 3010526986
- 3013596024
- 9617192
Source Documents#
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases