Capnocheck
FDA 510(k) K941982 · Bci, Inc.
510(k) numberK941982
Submission
- Device name
- Capnocheck
- Applicant
- Bci, Inc.
Waukesha, WI, US - Received
- April 25, 1994
- Decision date
- October 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
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| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK · Traditional | Nihon Kohden Corporation | 06/10/2025SE |
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| K240937 | Aim (N/A)CCK · Traditional | Inventeur, LLC | 12/16/2024SE |
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| 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 |
|---|---|---|
| K030407 | Advisor, Model 9200CCK · Traditional | 08/19/2003SE |
| K031742 | Bci 6004 Nibp Monitor with Nellcor Pulse OximeterDQA · Traditional | 08/18/2003SE |
| K020739 | Bci 3178 Pediatric Pulse Oximetry SensorDQA · Traditional | 06/03/2002SE |
| K020350 | Bci 3180 Pulse OximeterDQA · Traditional | 04/30/2002SE |
| K013862 | Bci 1621 Oximetry Data Management ProgramDQA · Traditional | 02/21/2002SE |
| K013171 | 3420 Digit Pulse Oximeter, Model 3420DQA · Traditional | 01/03/2002SE |
| K011156 | Bci 3403 Sleep Screening Pulse OximeterDQA · Traditional | 06/14/2001SE |
| K010770 | Bci Advisor Vital Signs Monitor (9200)MWI · Traditional | 06/12/2001SE |
| K011177 | Bci Advisor Vital Signs Monitor (9200)DPS · Traditional | 05/23/2001SE |
| K001770 | Bci M4529A Oem Digital Handheld Oximeter, Model M4529ADQA · Special | 07/05/2000SE |
Questions and answers
When was Capnocheck cleared by the FDA?
Capnocheck (K941982) received a 510(k) decision of Substantially Equivalent on October 17, 1994, 175 days after the submission was received.
What is the product code of K941982?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.