Lifespan CO2
FDA 510(k) K812643 · Biochem International, Inc.
510(k) numberK812643
Submission
- Device name
- Lifespan CO2
- Applicant
- Biochem International, Inc.
Mchenry, IL, US - Received
- September 16, 1981
- Decision date
- November 16, 1981
- 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 Lifespan CO2 cleared by the FDA?
Lifespan CO2 (K812643) received a 510(k) decision of Substantially Equivalent on November 16, 1981, 61 days after the submission was received.
What is the product code of K812643?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.