Clearance Summary
MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly received FDA 510(k) clearance under submission number K180902, sponsored by Medipines Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2019-01-11.
- Submission: K180902
- Applicant / Sponsor: Medipines Corporation
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 2019-01-11
Classification & Regulation
This clearance is catalogued under FDA product code CCK and 21 CFR 868.1400, within the Anesthesiology review panel as a Class II device.