Gas Sampling Lines
FDA 510(k) K023579 · Promedic, Inc.
510(k) numberK023579
Submission
- Device name
- Gas Sampling Lines
- Applicant
- Promedic, Inc.
Mccordsville, IN, US - Received
- October 24, 2002
- Decision date
- January 28, 2003
- 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 Gas Sampling Lines cleared by the FDA?
Gas Sampling Lines (K023579) received a 510(k) decision of Substantially Equivalent on January 28, 2003, 96 days after the submission was received.
What is the product code of K023579?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.