Ecolyzer #200/COHB Analyzer Sys
FDA 510(k) K832655 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK832655
Submission
- Device name
- Ecolyzer #200/COHB Analyzer Sys
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- August 8, 1983
- Decision date
- September 26, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1430
- Specialty
- Anesthesiology
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Questions and answers
When was Ecolyzer #200/COHB Analyzer Sys cleared by the FDA?
Ecolyzer #200/COHB Analyzer Sys (K832655) received a 510(k) decision of Substantially Equivalent on September 26, 1983, 49 days after the submission was received.
What is the product code of K832655?
The FDA product code is CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1430.