Capnocheck Plus
FDA 510(k) K970209 · Bci Intl., Inc.
510(k) numberK970209
Submission
- Device name
- Capnocheck Plus
- Applicant
- Bci Intl., Inc.
Waukesha, WI, US - Received
- January 21, 1997
- Decision date
- April 18, 1997
- 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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More from Southmedic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K991410 | 3402 Handheld Pulse OximeterDQA · Traditional | 06/09/1999SE |
| K991086 | Capnocheck II, Model 8400CCK · Traditional | 06/09/1999SE |
| K984618 | Bci Mini-Torr Plus, Model 6004DXN · Traditional | 03/25/1999SE |
| K983796 | 6004 Nibp Monitor with TemperatureDXN · Traditional | 01/22/1999SE |
| K982279 | Vital Signs Monitor; Advisor Model # Bci 9200MHX · Traditional | 09/25/1998SE |
| K981939 | Autocorr Plus; 3404 Oximeter/Ecg MonitorDQA · Traditional | 08/20/1998SE |
| K980714 | Bci 3401 Handheld Pulse OximeterDQA · Traditional | 03/25/1998SE |
| K974697 | Reusable Finger Sensor 3444DQH · Traditional | 03/11/1998SE |
| K970801 | Bci Model 6004 Nibp Monitor (6004)DXN · Traditional | 11/12/1997SE |
| K963496 | Oxi TempDQA · Traditional | 11/26/1996SE |
Questions and answers
When was Capnocheck Plus cleared by the FDA?
Capnocheck Plus (K970209) received a 510(k) decision of Substantially Equivalent on April 18, 1997, 87 days after the submission was received.
What is the product code of K970209?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.