Emma Analyzer (Kpa & MMHG); Emma Monitor (Kpa & MMHG)
FDA 510(k) K072813 · Phasein AB
510(k) numberK072813
Submission
- Device name
- Emma Analyzer (Kpa & MMHG); Emma Monitor (Kpa & MMHG)
- Applicant
- Phasein AB
Madison, WI, US - Received
- October 1, 2007
- Decision date
- December 28, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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| K251641 | GF-310R Multigas Unit (GF-310R)CCK · Traditional | Nihon Kohden Corporation | 08/12/2026SE |
| K261633 | VisuBreathCCK · Traditional | Affirm Medical Technologies II, LLC | 07/14/2026SE |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN)CCK · Traditional | Covidien, LLC | 05/01/2026SE |
| K250148 | Medical Gas Analyzer (AG200)CCK · Traditional | Prior Care Science Technology, Ltd. | 08/28/2025SE |
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| K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2…CCK · Traditional | Barbaras Development, Inc. | 06/04/2025SE |
| K240937 | Aim (N/A)CCK · Traditional | Inventeur, LLC | 12/16/2024SE |
| K230915 | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen MaskCCK · Traditional | Vyaire Medical, Inc. | 11/12/2024SE |
| K212425 | MicroTrend SystemCCK · Traditional | Exostat Medical, Inc. | 11/07/2024SE |
| K222511 | Oxy2ProCCK · Traditional | Southmedic, Inc. | 11/21/2023SE |
More from Southmedic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K123043 | Irma C02 Model 200101; Irma Ax 200601CCK · Special | 10/25/2012SE |
| K103604 | Isa CO2, Isa Ax+, Isa Or+CCK · Traditional | 04/06/2011SE |
| K081601 | Veo Multigas Monitor for Pocket PCCCK · Traditional | 09/04/2008SE |
| K063167 | Emma Analyzer (Kpa) and (MMHG); Emma Monitor (Kpa) and (MMHG)CCK · Traditional | 02/06/2007SE |
Questions and answers
When was Emma Analyzer (Kpa & MMHG); Emma Monitor (Kpa & MMHG) cleared by the FDA?
Emma Analyzer (Kpa & MMHG); Emma Monitor (Kpa & MMHG) (K072813) received a 510(k) decision of Substantially Equivalent on December 28, 2007, 88 days after the submission was received.
What is the product code of K072813?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.