510(k) K180902
K180902 is an FDA 510(k) premarket notification submitted by Medipines Corporation for the device "MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly". The FDA issued a decision of Substantially Equivalent on Jan 11, 2019. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 11, 2019
- Date Received
- Apr 6, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1400
- Review Panel
- AN
- Submission Type
- 510(k)