Dynex CO2/2000, CO2 Analyzer
FDA 510(k) K862543 · Analytical Products, Inc.
510(k) numberK862543
Submission
- Device name
- Dynex CO2/2000, CO2 Analyzer
- Applicant
- Analytical Products, Inc.
Belmont, CA, US - Received
- July 3, 1986
- Decision date
- July 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Dynex CO2/2000, CO2 Analyzer cleared by the FDA?
Dynex CO2/2000, CO2 Analyzer (K862543) received a 510(k) decision of Substantially Equivalent on July 15, 1986, 12 days after the submission was received.
What is the product code of K862543?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.