Loflo C5 CO2 Sensor
FDA 510(k) K053174 · Respironics Novametrix, LLC
510(k) numberK053174
Submission
- Device name
- Loflo C5 CO2 Sensor
- Applicant
- Respironics Novametrix, LLC
Wallingford, CT, US - Received
- November 14, 2005
- Decision date
- January 12, 2006
- 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 Loflo C5 CO2 Sensor cleared by the FDA?
Loflo C5 CO2 Sensor (K053174) received a 510(k) decision of Substantially Equivalent on January 12, 2006, 59 days after the submission was received.
What is the product code of K053174?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.