510(k) K053204
- Device
- INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A
- Applicant
- DRAEGER MEDICAL AG & CO. KGAA
- 510(k) number
- K053204
- Product code
- CCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-02-03
- Date received
- 2005-11-16
- 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
- MONICA FERRANTE
- Address
- 3155 Quarry Rd. Telford PA US 18969 18969
FDA Registration Numbers#
- 3006713849
- 3002807267
- 9616088
- 2183646
- 3014579161
- 3008716327
- 3010390468
- 3010317211
- 3013298431
- 3021559257
- 3006125362
- 3006547005
- 8030229
- 2025816
- 2134752
- 3004977335
- 3003800159
- 3013060098
- 3011137372
- 3015967359
- 2221819
- 3003674698
- 3016674095
- 3004415070
- 3038259592
- 3049808762
- 3014541700
- 2518422
- 3000126629
- 1319639
- 3005587132
- 3032109181
- 9610849
- 3008867836
- 3015168843
- 3009754460
- 3013783488
- 8044004
- 3012251275
- 3021343210
- 3007695715
- 3001313714
- 3017202422
- 8022257
- 3007603826
- 3012528160
- 3010157426
- 3043226252
- 3007413079
- 3013501110
- 3003589956
- 3003832357
- 3012733231
- 9615102
- 3010817335
- 3005783425
- 3008729547
- 3007307487
- 9710567
- 3010887638
- 3014479313
- 3009607734
- 3029871637
- 3018094310
- 1526012
- 9617566
- 3009973336
- 2016493
- 3016931915
- 8021995
- 3010419931
- 2320762
- 3009327445
- 9617192
- 9611252
- 3009499478
- 3001570235
- 3005877899
- 3015272694
- 3017422354
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#
summary
FDA Review#
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