510(k) K072813
- Device
- EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG)
- Applicant
- PHASEIN AB
- 510(k) number
- K072813
- Product code
- CCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-12-28
- Date received
- 2007-10-01
- 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
- DAVID WEISSBURG
- Address
- 4213 Winnequah Dr. Madison WI US 53716 53716
FDA Registration Numbers#
- 3004050971
- 3038913749
- 3012421607
- 3011503227
- 2134752
- 9616088
- 3008717264
- 3030154814
- 1061124
- 3013783488
- 3016852448
- 3012359877
- 3003263092
- 1319447
- 3016931915
- 3009499478
- 3021343210
- 3006547005
- 3013060098
- 2016493
- 3016674095
- 1000604079
- 3017844574
- 3005998497
- 3006606827
- 8030673
- 2529489
- 3011120183
- 3006713849
- 3006733253
- 3007413079
- 3009973336
- 3011137372
- 3016964847
- 1000122786
- 3010419931
- 3008058135
- 3010817335
- 1000484830
- 3015997711
- 3016678045
- 3005135175
- 3010703925
- 3005587132
- 3003630387
- 8022257
- 3031158
- 3019388613
- 3006536657
- 3010882708
- 2648727
- 3009001657
- 3010317211
- 3005873568
- 3006061749
- 3017609572
- 3027256461
- 9610816
- 3005783425
- 9617566
- 3003591740
- 3013298431
- 3010838917
- 9617192
- 3012528160
- 3038259592
- 3007481893
- 3015876
- 9710644
- 3008363989
- 1450653
- 3013652261
- 3030733800
- 1417592
- 9681384
- 3007603826
- 3008867836
- 3014479313
- 3010272829
Source Documents#
Other 510(k) Records For Product Code CCK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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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