CO2/02 Monitor Multinex
FDA 510(k) K872024 · Datascope Corp.
510(k) numberK872024
Submission
- Device name
- CO2/02 Monitor Multinex
- Applicant
- Datascope Corp.
Paramus, NJ, US - Received
- May 26, 1987
- Decision date
- March 31, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCI – Analyzer, Gas, Nitrogen, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1690
- Specialty
- Anesthesiology
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Questions and answers
When was CO2/02 Monitor Multinex cleared by the FDA?
CO2/02 Monitor Multinex (K872024) received a 510(k) decision of Substantially Equivalent on March 31, 1988, 310 days after the submission was received.
What is the product code of K872024?
The FDA product code is CCI – Analyzer, Gas, Nitrogen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1690.