Capno Probe a
FDA 510(k) K984579 · Optical Sensors, Inc.
510(k) numberK984579
Submission
- Device name
- Capno Probe a
- Applicant
- Optical Sensors, Inc.
Eden Prairie, MN, US - Received
- December 23, 1998
- Decision date
- December 21, 2000
- 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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Questions and answers
When was Capno Probe a cleared by the FDA?
Capno Probe a (K984579) received a 510(k) decision of Substantially Equivalent on December 21, 2000, 729 days after the submission was received.
What is the product code of K984579?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.