Engstrom Eliza + CO2 Analyzer
FDA 510(k) K890112 · Gambro, Inc.
510(k) numberK890112
Submission
- Device name
- Engstrom Eliza + CO2 Analyzer
- Applicant
- Gambro, Inc.
Lincolnshire, IL, US - Received
- January 11, 1989
- Decision date
- March 15, 1989
- 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 Engstrom Eliza + CO2 Analyzer cleared by the FDA?
Engstrom Eliza + CO2 Analyzer (K890112) received a 510(k) decision of Substantially Equivalent on March 15, 1989, 63 days after the submission was received.
What is the product code of K890112?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.