Siemens SC 9000 ETCO2 Module
FDA 510(k) K954632 · Siemens Medical Solutions USA, Inc.
510(k) numberK954632
Submission
- Device name
- Siemens SC 9000 ETCO2 Module
- Applicant
- Siemens Medical Solutions USA, Inc.
Danvers, MA, US - Received
- October 6, 1995
- Decision date
- February 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Siemens SC 9000 ETCO2 Module cleared by the FDA?
Siemens SC 9000 ETCO2 Module (K954632) received a 510(k) decision of Substantially Equivalent on February 5, 1996, 122 days after the submission was received.
What is the product code of K954632?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.