510(k) K982969
- Device
- NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847
- Applicant
- NONIN MEDICAL, INC.
- 510(k) number
- K982969
- Product code
- CCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-08-12
- Date received
- 1998-08-25
- 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
- RICHARD P BENNETT
- Address
- 2605 Fernbrook Ln., N. Plymouth MN US 55447 55447
FDA Registration Numbers#
- 3008717264
- 9710644
- 3021343210
- 8044004
- 9710567
- 3015967359
- 1061124
- 3013500228
- 3000126629
- 3012528160
- 3012307300
- 3009490946
- 3010223399
- 3024706751
- 3012251275
- 3008806809
- 1722070
- 2134752
- 3011503227
- 3016674095
- 3013679558
- 9610105
- 8030673
- 1314417
- 3013826848
- 3004111573
- 3013513837
- 1000122786
- 3023272766
- 3012359877
- 3019388613
- 3006536657
- 3006648320
- 3021559257
- 3007603826
- 2320762
- 9710116
- 3009973336
- 3003630387
- 3004016520
- 3016964847
- 1000604079
- 3015168843
- 3012337868
- 3015272694
- 3031158
- 3017844574
- 3003971136
- 3016931915
- 3006061749
- 3003687189
- 3018783526
- 3009129579
- 2936999
- 3011987967
- 3008058135
- 3009001657
- 3029871637
- 9615102
- 9617566
- 3007695715
- 1319639
- 3013060098
- 3005767446
- 3017202422
- 3032109181
- 3043226252
- 3010419931
- 3007207474
- 3008716327
- 3009499478
- 3014541700
- 3017178358
- 3016678045
- 3008363989
- 1043214
- 3006713849
- 3012421607
- 3004415095
Source Documents#
Other 510(k) Records For Product Code CCK #
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|---|---|---|---|
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| 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 |
| K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories | GE Healthcare Finland Oy | 2021-10-21 |
Legacy Summary#
summary
FDA Review#
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