510(k) K013845
- Device
- MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE
- Applicant
- ORIDION MEDICAL 1987 LTD.
- 510(k) number
- K013845
- Product code
- CCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-29
- Date received
- 2001-11-20
- 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
- SANFORD BROWN
- Address
- 7 Hamarpe St. P.O. Box 45025 Har Hotzvim Industrial Park Jerusalem IL 91450 91450
FDA Registration Numbers#
- 3009831876
- 3008806809
- 3012528160
- 3013557562
- 3009077524
- 3016678045
- 3023272766
- 3006061749
- 3010427901
- 3010272829
- 1526012
- 3003832357
- 3009129579
- 3017844574
- 3014479313
- 3007413079
- 1219324
- 9615102
- 3013652261
- 3000126629
- 3005587132
- 8020864
- 3006733253
- 3003687189
- 2518422
- 3007616088
- 3006536657
- 1417592
- 9710644
- 3016931915
- 3016964847
- 3008058135
- 1423537
- 1319447
- 3004050971
- 3044156918
- 3006648320
- 9617192
- 3013060098
- 8021995
- 2529489
- 3004415095
- 3029871637
- 3015967359
- 3006534321
- 3009490946
- 3010419931
- 3005135175
- 3017178358
- 2023529
- 3009607734
- 2025816
- 1066270
- 1000484830
- 9610816
- 3010411911
- 3003674698
- 8030229
- 3007238566
- 3031158
- 3014541700
- 3024706751
- 3004415070
- 3001313714
- 8022032
- 3011353843
- 3010817335
- 3009156722
- 3006979678
- 3010317211
- 3011137372
- 3012733231
- 3004906872
- 1061124
- 3004111573
- 3003971136
- 3017422354
- 3016674095
- 8044169
Source Documents#
Other 510(k) Records For Product Code CCK #
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|---|---|---|---|
| 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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