Datex-Ohmeda S/5 Interface Module E-Int
FDA 510(k) K052880 · GE Healthcare
510(k) numberK052880
Submission
- Device name
- Datex-Ohmeda S/5 Interface Module E-Int
- Applicant
- GE Healthcare
Needham, MA, US - Received
- October 12, 2005
- Decision date
- November 2, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Datex-Ohmeda S/5 Interface Module E-Int cleared by the FDA?
Datex-Ohmeda S/5 Interface Module E-Int (K052880) received a 510(k) decision of Substantially Equivalent on November 2, 2005, 21 days after the submission was received.
What is the product code of K052880?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.