Mass Spectrometry Monitoring Line Cononectors
FDA 510(k) K925167 · Merit Medical Systems, Inc.
510(k) numberK925167
Submission
- Device name
- Mass Spectrometry Monitoring Line Cononectors
- Applicant
- Merit Medical Systems, Inc.
Indianapolis, IN, US - Received
- October 13, 1992
- Decision date
- January 22, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Mass Spectrometry Monitoring Line Cononectors cleared by the FDA?
Mass Spectrometry Monitoring Line Cononectors (K925167) received a 510(k) decision of Substantially Equivalent on January 22, 1993, 101 days after the submission was received.
What is the product code of K925167?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.